On August 3, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that Hugh Young Rienhoff, Jr., MD, CEO of Imago BioSciences, will participate in an analyst led Fireside Chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 1:10 pm Eastern Time / 10:10 am Pacific Time (Press release, Imago BioSciences, AUG 3, 2022, View Source [SID1234617375]).

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Interested parties can access the live webcast of the Fireside Chat by visiting the Investor Relations section of the company’s website at ir.imagobio.com. A webcast replay will be available after the conclusion of the event for approximately 90 days.

On August 3, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that financial results for the second quarter of 2022 and provided a business update (Press release, Regeneron, AUG 3, 2022, View Source [SID1234617391]).

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"The second quarter of 2022 was distinguished by record net product sales of EYLEA, Dupixent, and Libtayo, as well as multiple regulatory achievements for Dupixent, including U.S. approvals for atopic dermatitis among very young patients and for eosinophilic esophagitis in adults and adolescents, as well as European approval for pediatric asthma," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In addition, we have continued to strengthen our oncology franchise, including through the purchase of worldwide rights to Libtayo as well as encouraging but preliminary anti-tumor activity observed at higher doses of our novel PSMAxCD28 costimulatory bispecific in combination with Libtayo for advanced metastatic castration-resistant prostate cancer."

Financial Highlights

"We are pleased with our second quarter 2022 financial performance, including 20% revenue growth when excluding contributions from REGEN-COV. This demonstrates the continued strength of our core business," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Additionally, we updated our full-year 2022 financial guidance primarily to reflect the recently completed acquisition of Libtayo global rights from Sanofi, a transaction that we believe will deliver significant shareholder value over time. In the second half of 2022, we look forward to advancing our pipeline with important clinical data readouts in oncology and ophthalmology as well as continued commercial execution and prudent capital allocation to drive value creation for shareholders."

Business Highlights

Key Pipeline Progress
Regeneron has approximately 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent (dupilumab)

In June 2022, the U.S. Food and Drug Administration (FDA) approved Dupixent as the first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.
In May 2022, the FDA approved Dupixent for adults and adolescents aged 12 years and older with eosinophilic esophagitis (EoE).
In April 2022, the European Commission (EC) approved Dupixent for the treatment of severe asthma in children aged 6 to 11 years.
The Company and Sanofi announced positive results from a Phase 3 trial in children aged 1 to 11 years with EoE. The trial met its primary endpoint of histological disease remission at 16 weeks with both higher and lower dose weight-tiered regimens.
The FDA accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent for adults with prurigo nodularis, with a target action date of September 30, 2022. Regulatory applications have also been submitted in the European Union (EU) and Japan.
EYLEA (aflibercept) Injection

The FDA accepted for review the sBLA for EYLEA for an every-16-weeks dosing regimen in patients with diabetic retinopathy (DR), with a target action date of February 28, 2023.
REGN5678, a PSMAxCD28 costimulatory bispecific antibody

Reported preliminary, first-in-human data in combination with Libtayo in patients with advanced metastatic castration-resistant prostate cancer.
Antibodies to SARS-CoV-2 virus

The Company is continuing to progress investigational "next generation" antibodies that are active against multiple variants including those of Omicron-lineage.
REGN5381, an agonist antibody to NPR1

A Phase 2 study in heart failure was initiated.
Corporate and Business Development Updates

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc. for a total equity value of approximately $250 million. In connection with the acquisition, the Company obtained the rights to vidutolimod (immune activator targeting TLR9), which is in clinical development for oncology.
Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi. Under the terms of the agreement, the Company made a $900 million up-front payment, and Sanofi is eligible to receive a $100 million regulatory milestone and up to an aggregate of $100 million in sales-based milestones upon achieving certain amounts of worldwide net product sales of Libtayo through 2023. The Company will also pay Sanofi a royalty on net product sales of Libtayo.
Also effective July 1, 2022, the Company will increase from 10% to 20% the share of its profits that are paid to Sanofi in connection with the development balance reimbursement under the antibody collaboration.
Second Quarter 2022 Financial Results

* Percentage not meaningful

** Effective July 1, 2022, the Company will record global net product sales of Libtayo.

Total revenues decreased by 44% to $2.857 billion in the second quarter of 2022, compared to $5.139 billion in the second quarter of 2021. Total revenues excluding REGEN-COV and Ronapreve(b) revenues for both periods increased by 20% to $2.849 billion in the second quarter of 2022, compared to the second quarter of 2021(a). There have been no sales of REGEN-COV in the United States during 2022 as the Company had completed its final deliveries of drug product under its agreements with the U.S. government as of December 31, 2021.

Sanofi collaboration revenue increased by 55% to $678 million in the second quarter of 2022, compared to the second quarter of 2021. This increase was primarily due to the Company’s share of profits from commercialization of antibodies, which were $497 million in the second quarter of 2022, compared to $328 million in the second quarter of 2021. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. Roche collaboration revenue decreased in the second quarter of 2022, compared to the second quarter of 2021, due to lower sales of Ronapreve.

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded.

** Beginning with the first quarter of 2022, the Company added this new line item to its Statements of Operations, which includes IPR&D acquired in connection with asset acquisitions as well as up-front/opt-in payments related to license and collaboration agreements. Amounts recorded in this line would have historically been recorded to R&D. This change does not affect previously reported non-GAAP results for the three and six months ended June 30, 2021 as the Company recorded no such charges during either of these periods.

GAAP and non-GAAP R&D expenses increased in the second quarter of 2022, compared to the second quarter of 2021, primarily due to higher headcount and headcount-related costs and an increase in clinical manufacturing activities, partly offset by lower costs incurred in connection with REGEN-COV development activities.
Acquired IPR&D in the second quarter of 2022 included a $195 million charge related to the Company’s acquisition of Checkmate Pharmaceuticals.
The increase in GAAP and non-GAAP SG&A expenses in the second quarter of 2022, compared to the second quarter of 2021, was primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses for EYLEA, partly offset by costs in 2021 for educational campaigns related to COVID-19 that did not recur in 2022.
GAAP and non-GAAP COGS decreased in the second quarter of 2022, compared to the second quarter of 2021, primarily due to the Company not recognizing any REGEN-COV net product sales in the United States during 2022.
Other Financial Information

GAAP other income (expense) included the recognition of net unrealized losses on equity securities of $164 million in the second quarter of 2022, compared to $409 million of net unrealized gains in the second quarter of 2021.

In the second quarter of 2022, the Company’s GAAP effective tax rate (ETR) was 11.5%, compared to 17.4% in the second quarter of 2021. The decrease in the GAAP ETR was primarily driven by the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, the impact of income earned in the United States during 2021 related to REGEN-COV, and, to a lesser extent, stock-based compensation. In the second quarter of 2022, the non-GAAP ETR was 13.6%, compared to 17.0% in the second quarter of 2021.

GAAP net income per diluted share was $7.47 in the second quarter of 2022, compared to $27.97 in the second quarter of 2021. Non-GAAP net income per diluted share was $9.77 in the second quarter of 2022, compared to $25.80 in the second quarter of 2021. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

During the second quarter of 2022, the Company repurchased shares of common stock under its share repurchase program, and recorded the cost of the shares received, or $394 million, as Treasury Stock. As of June 30, 2022, $2.099 billion remained available for share repurchases under the program.

2022 Financial Guidance(d)

The Company’s full year 2022 financial guidance consists of the following components (inclusive of updates made in connection with the Company’s purchase of Sanofi’s stake in Libtayo and acquisition of Checkmate Pharmaceuticals):

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded.

** ETR guidance excludes the impact of the provision requiring capitalization and amortization of R&D expenses enacted as part of the Tax Cuts and Job Act (TCJA), as management’s current expectation is it will be deferred or repealed by Congress in 2022. If this provision of the TCJA is not deferred or repealed, the Company would expect its ETR to be lower than the guidance disclosed herein.

A reconciliation of full year 2022 GAAP to non-GAAP financial guidance is included below:

This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, total revenues excluding REGEN-COV and Ronapreve, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control (such as the Company’s stock price on the dates share-based grants are issued or changes in the fair value of the Company’s investments in equity securities) or items that are not associated with normal, recurring operations (such as restructuring- or integration-related expenses). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company’s operations’ ability to generate cash flows. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP.

The casirivimab and imdevimab antibody cocktail is known as REGEN-COV in the United States and Ronapreve in other countries. The Company records net product sales of REGEN-COV in the United States and Roche records net product sales of Ronapreve outside the United States.

The Company’s collaborators provide it with estimates of the collaborators’ respective sales and the Company’s share of the profits or losses (if applicable) from commercialization of products for the most recent fiscal quarter. These estimates are revised, if necessary, in subsequent periods if the Company’s actual share of the profits or losses differ from those estimates.

The Company’s 2022 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.

Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold.

Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues.

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2022 financial and operating results on Wednesday, August 3, 2022, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron’s website at View Source Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On August 3, 2022 Jubilant Therapeutics Inc., a biopharmaceutical Company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported U.S. Food and Drug Administration (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma (Press release, Jubilant Radiopharma, AUG 3, 2022, View Source [SID1234617428]).

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Jubilant Therapeutics Inc. announces US FDA clearance of& IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor,& for treatment of solid tumors with brain metastases and primary brain tumors
Jubilant Therapeutics Inc. announces US FDA clearance of& IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor,& for treatment of solid tumors with brain metastases and primary brain tumors
The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778. The study population in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts will include patients with active brain metastases and high-grade gliomas.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics’ proven discovery engine and structure-based drug discovery expertise."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options. The incidence of brain metastasis is increasing due to improved therapies, increased imaging of neurologically asymptomatic patients and patients living longer. Our team has developed a unique capability to optimize brain penetration for precision oncology therapeutics. In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others."

About JBI-778

JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers. JBI-778 is in development for the treatment of patients with advanced cancer with brain metastasis, and patients with high-grade glioma all of whom have limited treatment options. It has a unique mechanism of action compared to existing PRMT5 inhibitors by being substrate-competitive and S-adenosylmethoinine (SAM) cooperative, combined with a high brain exposure that enables targeting of both primary brain tumors and CNS metastasis. The substrate competitive profile appears to provide enhanced selectivity in the biological system by not interfering with the functions of SAM and shows a good tolerability profile in toxicological studies.

Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 3, 2022 Moderna Therapeutics reported financial results and provided business updates for the second quarter of fiscal year 2022 (Press release, Moderna Therapeutics, AUG 3, 2022, View Source/news/news-details/2022/Moderna-Reports-Second-Quarter-2022-Financial-Results-and-Provides-Business-Updates/default.aspx" target="_blank" title="View Source/news/news-details/2022/Moderna-Reports-Second-Quarter-2022-Financial-Results-and-Provides-Business-Updates/default.aspx" rel="nofollow">View Source [SID1234618963]).

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"Today’s earnings represent a strong second quarter performance, with $10.8 billion in revenue for the first half of the year. We continue to have advance purchase agreements for expected delivery in 2022 of around $21 billion of sales. Given our strong financial position and commercial momentum, we are announcing today that the Board of Directors has approved a new share repurchase program for $3 billion," said Stéphane Bancel, Chief Executive Officer of Moderna. "Despite the slowing economy and challenges in the biotech industry, Moderna is in a unique position: a platform to drive scale and speed in research of new medicines, a strong balance sheet with $18 billion of cash and an agile, mission-driven team of over 3,400 people and growing. We will continue to invest and grow as we have never been as optimistic about Moderna’s future. Right now, we have four infectious disease vaccines in Phase 3 trials, and later this year, we expect important data from proof-of-concept studies in rare diseases and immuno-oncology. Our teams are actively working to prepare these new product launches to help patients and drive growth. This is an exciting time for Moderna as we continue to see significant scientific and business momentum."

Recent progress includes:

Respiratory Vaccines

Received U.S. FDA authorization for dose-dependent, two-dose primary series of mRNA-1273 inchildren and adolescents 6 months to 17 years of age; similar approvals or authorizations have been received from international regulatory authorities in more than 40 countries for children and adolescents 6 years to 17 years of age, and in the United States, Canada, Australia and other jurisdictions for children 6 months to 5 years of age
Positive data on booster dose of bivalent candidate based on the wild-type and Omicron subvariant BA.1 (mRNA-1273.214)
Began rapid development of mRNA-1273.222 , which contains the BA.4/5 Omicron strain and is being developed in accordance with recent FDA recommendations
Moderna continues to progress respiratory vaccine pipeline with ongoing Phase 2 data on next-generation, refrigerator-stable COVID vaccine candidate (mRNA-1283)
Phase 3 safety and immunogenicity trial started in June in the Southern Hemisphere for seasonal flu vaccine candidate (mRNA-1010) to support potential accelerated approval. Company is preparing for Phase 3 efficacy study in fall 2022 (if needed); Flu (mRNA-1020/-30) Phase 1/2 trial fully enrolled
Combination COVID + flu (mRNA-1073) Phase 1/2 fully enrolled; combination COVID + flu + RSV (mRNA-1230) in preclinical studies, expected to start Phase 1 trial later this year; endemic human coronavirus (mRNA-1287) in preclinical
Pediatric hMPV + PIV3 (mRNA-1653) Phase 1b fully enrolled; pediatric RSV + hMPV (mRNA-1365) in preclinical
Older adults RSV Phase 3 (mRNA-1345) , known as ConquerRSV, is ongoing; pediatric RSV in Phase 1
Latent Vaccines

CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing
EBV vaccine (to prevent infectious mononucleosis) (mRNA-1189) Phase 1 is ongoing; EBV vaccine (to prevent EBV sequelae) (mRNA-1195) in preclinical studies
HIV vaccines (mRNA-1644 and mRNA-1574) Phase 1 trials are ongoing
HSV vaccine (mRNA-1608) and VZV vaccine (mRNA-1468) in preclinical studies
Public Health Vaccines

Zika vaccine (mRNA-1893) ongoing in a Phase 2 study
Nipah vaccine (mRNA-1215) Phase 1 study, led by the National Institutes of Health (NIH), is ongoing (first participant dosed in July)
mRNA therapeutics

The first and second cohorts of the Phase 1/2 Paramount study of propionic acidemia (PA) candidate (mRNA-3927) are fully enrolled. Moderna is enrolling patients into additional cohorts.
The first cohort of the Phase 1/2 Landmark study of methylmalonic acidemia (MMA) candidate (mRNA-3705) is fully enrolled. Moderna is enrolling patients into additional cohorts.
GSD1a (mRNA-3745) Phase 1 trial first patient dosed
PKU (mRNA-3283), CN-1 (mRNA-3351) and cystic fibrosis in preclinical studies (with Vertex) (VXc-522)
PCV (mRNA-4157) Phase 1 ongoing; Phase 2 fully enrolled, data expected in 4Q 2022
Checkpoint vaccine (mRNA-4359) has received safe to proceed and has an open Investigational New Drug (IND) designation from the U.S. FDA
AZD8601 , a mRNA encoding VEGF therapeutic, has been returned to Moderna from AstraZeneca. We are evaluating next steps for the program
Moderna now has 46 programs in development across 43 development candidates 1 , of which 31 are currently in active clinical trials. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 120 peer reviewed manuscripts.

Second Quarter 2022 Financial Results

Revenue: Total revenue was $4.7 billion and $10.8 billion for the three and six months ended June 30, 2022, respectively, compared to $4.4 billion and $6.3 billion for the same periods in 2021. The revenue increase in 2022 was primarily due to increased product sales from sales of the Company’s COVID-19 vaccine. Product sales for the second quarter of 2022 were $4.5 billion, increased by $334 million, or 8%, compared to the same period in 2021, primarily driven by a higher average selling price due to customer mix. Product sales for the six months ended June 30, 2022 were $10.5 billion, increased by $4.5 billion, or 76%, compared to the same period in 2021, driven by increased sales of the Company’s COVID-19 vaccine.
Cost of Sales: Cost of sales was $1.4 billion, or 30% of product sales, for the second quarter of 2022, including third-party royalties of $157 million. Cost of sales as a percentage of product sales for the second quarter of 2022 increased by 12 percentage points, from 18% in the same period in 2021. This includes a charge of $499 million for inventory write-downs related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, as well as a loss on firm purchase commitments of $184 million and an expense for unutilized external manufacturing capacity of $131 million. These charges are driven by a substantial reduction of our expected deliveries to COVAX and deferral of deliveries to other customers, particularly to the European Union.
Research and Development Expenses: Research and development expenses were $710 million and $1.3 billion for the three and six months ended June 30, 2022, respectively, compared to $421 million and $822 million for the same periods in 2021. The growth in spending in 2022 was mainly due to increases in clinical trial expenses, personnel-related costs, and consulting and outside services.
Selling, General and Administrative Expenses: Selling, general and administrative expenses were $211 million and $479 million for the three and six months ended June 30, 2022, respectively, compared to $121 million and $198 million for the same periods in 2021. The growth in spending in 2022 was mainly due to increases in distributor fees and marketing expenses, ongoing digital investments, personnel-related costs, and a $50 million endowment given to the Moderna Charitable Foundation in the first quarter of 2022.
Provision for Income Taxes: The effective tax rate was 11% and 13% for the three and six months ended June 30, 2022, respectively, compared to 9% and 7% for the same periods in 2021. The increase in 2022 was primarily due to the benefit recorded in 2021 related to the release of the valuation allowance on the majority of our deferred tax assets. Income taxes were $277 million for the second quarter of 2022, decreased by $6 million compared to the same period in 2021, primarily due to a decrease in pre-tax income, partially offset by a higher effective tax rate.Income taxes were $849 million for the six months ended June 30, 2022, increased by $527 million compared to the same period in 2021, mainly due to an increase in pre-tax income and a higher effective tax rate.
Net Income: Net income was $2.2 billion and $5.9 billion for the three and six months ended June 30, 2022, respectively, compared to $2.8 billion and $4.0 billion for the same periods in 2021.
Earnings Per Share: Diluted EPS was $5.24 and $13.85 for the three and six months ended June 30, 2022, respectively, compared to $6.46 and $9.30 for the same periods in 2021.
Cash Position: Cash, cash equivalents and investments as of June 30, 2022 and December 31, 2021 were $18.1 billion and $17.6 billion, respectively.
Net Cash Provided By Operating Activities: Net cash provided by operating activities was $3.1 billion for the six months ended June 30, 2022, compared to $7.0 billion for the same period in 2021. Net cash provided by operating activities decreased in 2022, primarily attributable to revenue recognized from deferred revenue in excess of customer deposits received and increased income tax payments, partially offset by increased product sales and higher collection of receivables.
Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $219 million for the six months ended June 30, 2022, compared to $65 million for the same period in 2021. The increase was primarily driven by the Company’s business expansion.
Cash Used for Repurchases of Common Stock: Cash used for repurchases of common stock was $1.9 billion for the six months ended June 30, 2022. Moderna did not conduct share repurchases prior to the fourth quarter of 2021. From the end of the third quarter of 2021 to the end of the second quarter of 2022, the Company repurchased 16 million shares, reducing the number of common shares outstanding from 405 million to 392 million, more than offsetting 3 million shares of common stock issued in connection with equity compensation over this period.
2022 Financial Framework

Advance Purchase Agreements (APAs): Moderna’s APAs for product sales for which we expect to make delivery in 2022 are approximately $21 billion. This includes the recently announced agreement with the U.S. government for 70 million doses (option for 4 million pediatric doses has been exercised) and an adjustment for doses that remain unallocated by COVAX due to lack of demand. Moderna anticipates that for sales in the second half, sales will be greater in the fourth quarter than the third quarter, driven by the timing for approval of our updated COVID-19 vaccines and the related manufacturing ramp-up of new products.
Cost of Sales: Cost of sales as percentage of product sales are expected to be in the mid- 20s percentage range, with possible cost of sales in the high-20s in the event of further charges due to product updates.
Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses : Full year expenses are expected to be approximately $4 billion.
Tax Rate: The Company expects an effective tax rate for the full year in the low- to mid-teen percentage range
Capital Expenditures: Expect capital investments for 2022 in the range of $0.6-$0.8 billion.
Share Repurchase Program: The Board of Directors has authorized an additional share repurchase program for $3 billion in August 2022 to return excess capital to shareholders. The previous program of $1 billion announced in August 2021 was fully utilized as of the end of January 2022 and the $3 billion repurchase program announced in February 2022 is continuing and currently has approximately $1 billion outstanding.
Corporate Updates

Continued Growth: Moderna had approximately 3,400 employees as of June 30, 2022, compared to approximately 1,800 employees as of June 30, 2021
ESG Report: Moderna released its first annual ESG report, highlighting the company’s efforts and commitment to the environment, sustainability and governance
Company Recognition: Moderna made its Fortune 500 debut and was listed in the Financial Times list of the Americas’ Fastest Growing Companies of 2022
Science & Technology Day: Moderna hosted its 5 th Science and Technology Day, highlighting advances from its commitment to basic and applied sciences
Strategic Partnership with Government of the United Kingdom: Moderna and the United Kingdom government announced an agreement in principle to establish an mRNA Innovation and Technology Center in the UK
Strategic Partnership with Government of Canada: Moderna announced its plan to build a state-of-the-art mRNA vaccine manufacturing facility in Quebec that will support a long-term strategic partnership with the Government of Canada to enhance pandemic preparedness
Japan Marketing Authorization: Moderna has become the marketing authorization holder for Spikevax in Japan, following a transition from Takeda. Moderna continues to grow its footprint in Japan
Moderna & IAVI Partner on Global Health: Moderna and nonprofit scientific research organization IAVI announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health threats; Moderna and IAVI subsequently launched a first-in-Africa clinical trial of mRNA HIV vaccine development program (mRNA-1644)
Key 2022 Investor and Analyst Event Dates

R&D Day: September 8
ESG Day: November 10
Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, August 3, 2022.

To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: https://register.vevent.com/register/BI56aa5dacc77e41ebbba622851ac67f30
Webcast: View Source
The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .

MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Unaudited, in millions, except per share data)

Three Months Ended June 30, Six Months Ended June 30,

2022 2021 2022 2021
Revenue:

Product sales
$ 4,531 $ 4,197 $ 10,456 $ 5,930
Grant revenue
183 139 309 333
Collaboration revenue
35 18 50 28
Total revenue
4,749 4,354 10,815 6,291
Operating expenses:
Cost of sales
1,381 750 2,398 943
Research and development
710 421 1,264 822
Selling, general and administrative
211 121 479 198
Total operating expenses
2,302 1,292 4,141 1,963
Income from operations
2,447 3,062 6,674 4,328
Interest income
40 3 55 7
Other expense, net
(13 ) (2 ) (26 ) (12 )
Income before income taxes
2,474 3,063 6,703 4,323
Provision for income taxes
277 283 849 322
Net income
$ 2,197 $ 2,780 $ 5,854 $ 4,001

Earnings per share:
Basic
$ 5.55 $ 6.93 $ 14.66 $ 9.98
Diluted
$ 5.24 $ 6.46 $ 13.85 $ 9.30

Weighted average common shares used in calculation of earnings per share:
Basic
396 402 399 401
Diluted
419 431 423 430
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions, except per share data)

June 30, December 31,

2022 2021
Assets

Current assets:

Cash and cash equivalents
$ 2,873 $ 6,848
Investments
5,024 3,879
Accounts receivable
2,691 3,175
Inventory
1,921 1,441
Prepaid expenses and other current assets
1,054 728
Total current assets
13,563 16,071
Investments, non-current
10,162 6,843
Property and equipment, net
1,324 1,241
Right-of-use assets, operating leases
122 142
Restricted cash, non-current
12 12
Deferred tax assets
785 326
Other non-current assets
75 34
Total assets
$ 26,043 $ 24,669
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 181 $ 302
Accrued liabilities
1,780 1,472
Deferred revenue
4,093 6,253
Income taxes payable
349 876
Other current liabilities
409 225
Total current liabilities
6,812 9,128
Deferred revenue, non-current
405 615
Operating lease liabilities, non-current
87 106
Financing lease liabilities, non-current
641 599
Other non-current liabilities
113 76
Total liabilities
8,058 10,524
Stockholders’ equity:
Additional paid-in capital
2,413 4,211
Accumulated other comprehensive loss
(240 ) (24 )
Retained earnings
15,812 9,958
Total stockholders’ equity
17,985 14,145
Total liabilities and stockholders’ equity
$ 26,043 $ 24,669
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)

Six Months Ended June 30,

2022 2021
Operating activities

Net income
$ 5,854 $ 4,001
Adjustments to reconcile net income to net cash provided by operating activities:
Stock-based compensation
94 65
Depreciation and amortization
155 84
Amortization/accretion of investments
29 13
Deferred income taxes
(376 ) (72 )
Other non-cash items
15 -
Changes in assets and liabilities:
Accounts receivable
484 (629 )
Prepaid expenses and other assets
(324 ) (110 )
Inventory
(480 ) (596 )
Right-of-use assets, operating leases
20 (14 )
Accounts payable
(56 ) 44
Accrued liabilities
305 367
Deferred revenue
(2,370 ) 3,433
Income taxes payable
(527 ) 377
Operating lease liabilities
(19 ) 8
Other liabilities
263 63
Net cash provided by operating activities
3,067 7,034
Investing activities
Purchases of marketable securities
(8,734 ) (6,559 )
Proceeds from maturities of marketable securities
1,409 860
Proceeds from sales of marketable securities
2,506 1,706
Purchases of property and equipment
(219 ) (65 )
Investment in convertible notes
(35 ) -
Net cash used in investing activities
(5,073 ) (4,058 )
Financing activities
Proceeds from issuance of common stock through equity plans
29 64
Repurchase of common stock
(1,921 ) -
Changes in financing lease liabilities
(77 ) (62 )
Net cash (used in) provided by financing activities
(1,969 ) 2
Net (decrease) increase in cash, cash equivalents and restricted cash
(3,975 ) 2,978
Cash, cash equivalents and restricted cash, beginning of year
6,860 2,636
Cash, cash equivalents and restricted cash, end of period
$ 2,885 $ 5,614
Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: anticipated sales, including the timing of sales, under advance purchase agreements in 2022 and the associated dollar amounts to be received, which should not be construed as expected 2022 revenue; the timing of data from proof-of-concept studies in rare diseases and immuno-oncology; the repurchase by Moderna of shares of its common stock under its repurchase programs; potential accelerated approval of mRNA-1010 (flu); the timing of the Company’s Phase 1 trial of its combination COVID + flu + RSV vaccine candidate; COVID market dynamics; Moderna’s 2022 financial framework; Moderna’s plans to construct mRNA manufacturing facilities in the United Kingdom and Canada; and the potential of mRNA technology to address a range of global health threats. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.