On November 8, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the third quarter ended September 30, 2022 (Press release, Emergent BioSolutions, NOV 8, 2022, View Source [SID1234623415]).

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"For more than 20 years, Emergent has been a dependable partner to customers, including the U.S. and allied governments, in helping prepare for public health threats through our products, services, and development programs," said Robert G. Kramer, president and CEO. "As we continue to strengthen our operations, be guided by financial discipline, and evaluate opportunities for growth, we remain confident in our ability to deliver results for our patients, customers, and shareholders."

SELECT Q3 2022 AND OTHER RECENT BUSINESS UPDATES

Completed the acquisition from Chimerix of its worldwide rights to TEMBEXA(R) (brincidofovir), the first U.S. Food and Drug Administration (FDA) approved smallpox oral antiviral for all ages, following the award by the Biomedical Advanced Research and Development Authority (BARDA) of a 10-year procurement contract valued at up to $680 million to deliver 1.7 million doses of TEMBEXA to the U.S. government.
Initiated a Phase 1 study to evaluate the safety and immunogenicity of EBS-LASV, a recombinant VSV-vectored Lassa virus vaccine candidate being developed for prevention of disease caused by Lassa virus infection.
Completed enrollment of participants in the pivotal Phase 3 study evaluating safety and immunogenicity of the Company’s single-dose CHIKV VLP vaccine candidate in adults aged 12 to 64; recruitment continues for the second Phase 3 study focused on adults 65 and older.
Announced data from a Phase 2 study evaluating the CHIKV VLP vaccine candidate in prior recipients of other investigational alphavirus vaccines. The study demonstrated that CHIKV VLP was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus.
Published in early October the 2021 ESG Report (available at View Source).
Q3 2022 FINANCIAL PERFORMANCE (1)

Product Sales, net
Anthrax vaccines
For Q3 2022, revenues from Anthrax vaccines increased $8.6 million as compared to Q3 2021. The increase is largely driven by timing of deliveries to the U.S. government (USG), specifically the Strategic National Stockpile (SNS). The Company received an AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) contract modification in September 2021 valued at approximately $399.0 million to deliver additional AV7909 doses through March 2023.

Nasal naloxone products
For Q3 2022, revenues from nasal naloxone products decreased $45.4 million as compared to Q3 2021. The decrease was driven by a reduction in commercial retail sales following the launch of a generic in December 2021. This decrease was partially offset by strong growth in unit sales of branded NARCAN(naloxone HCl) Nasal Spray to public interest customers in the U.S., as well as from sales of the authorized generic product licensed to Sandoz, which launched in December 2021.

ACAM2000
For Q3 2022, revenues from ACAM2000 decreased $31.7 million as compared to Q3 2021. The decrease was due to a lower number of doses sold to the USG, partially offset by an increased number of doses sold to non-U.S. customers at a higher price per dose.

Other (4)
For Q3 2022, revenues from other product sales decreased $15.8 million as compared to Q3 2021. The decrease was primarily due to sales of two of the Company’s Government/Medical Countermeasure (MCM) products: i) VIGIV [Vaccinia Immune Globulin Intravenous (Human)], driven by timing of deliveries to the SNS; and ii) BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], driven by timing of deliveries to international customers, partially offset by an increase in sales of Anthrasil [Anthrax Immune Globulin Intravenous (human)], RSDL (Reactive Skin Decontamination Lotion Kit) and Vivotif (Typhoid Vaccine Live Oral Ty21a).

Contract Development and Manufacturing (CDMO)
CDMO Services
For Q3 2022, revenues from CDMO services decreased $76.4 million as compared to Q3 2021. This decrease is largely due to lower combined revenues of $59.1 million from AstraZeneca and Janssen reflecting the impact of reduced production activities at the Bayview facility as a result of a cessation of manufacturing activities under the AstraZeneca contract which occurred in 2021, and a pause and eventual cessation of manufacturing activities under the Janssen contract which began in Q1 2022. The decrease also reflects reduced production at the Camden facility in the quarter driven by additional investments in strengthening quality and compliance that restricted the Company’s ability to optimally utilize the existing capacity at the site. These declines in revenues were partially offset by an increase in services revenues earned at the Company’s Winnipeg facility.

CDMO Leases
For Q3 2022, revenues from CDMO leases increased $71.2 million as compared to Q3 2021. The increase was primarily due to the reversal of $86.0 million of revenue in Q3 2021 related to the Company’s public-private COVID-19 development partnership with BARDA in November 2021, partially offset by a $15.1 million decrease in lease revenues related to the Janssen contract.

Contracts and Grants
For Q3 2022, revenues from contracts and grants were consistent with Q3 2021.

Cost of Product Sales
For Q3 2022, cost of product sales decreased $17.7 million as compared to Q3 2021. The decrease is primarily due to a change in volume of product sales.

Cost of CDMO
For Q3 2022, cost of CDMO decreased $51.2 million as compared to Q3 2021. The decrease is primarily due to reduced production activities across our CDMO network in Q3 2022 compared to Q3 2021 resulting in decreased raw materials consumption. These decreases were partially offset by increased costs at the Company’s Camden facility due to additional investments in quality enhancement and improvement initiatives.

Research and Development
For Q3 2022, research and development expenses decreased $10.4 million as compared to Q3 2021. The decrease is primarily due to a decline in costs for the Company’s COVID-19 therapeutic and other product candidates.

Selling, General and Administrative
For Q3 2022, selling, general and administrative expenses decreased $1.9 million due to reduced professional services and marketing costs partially offset by higher travel costs.

Additional Financial Information

Segment Information
During Q1 2022, the Company began assessing its operating performance by focusing on two reportable segments: 1) a products segment (Products) consisting of the MCM and Commercial products business lines; and 2) a services segment (Services) consisting of the CDMO business line. The Company evaluates the performance of these reportable segments based on revenue and adjusted gross margin. Segment revenue includes external customer sales but does not include inter-segment services. The Company does not allocate contracts and grants, R&D, SG&A, amortization of intangible assets, interest and other income (expense) or taxes to its evaluation of the performance of these segments.

For the three months ended September 30, 2022, Product gross margin and Product adjusted gross margin decreased $66.6 million and $66.9 million, respectively, as compared to the three months ended September 30, 2021. The decreases in Product gross margin and Product adjusted gross margin are primarily due to decreased volumes and changes in mix.

For the nine months ended September 30, 2022, Product gross margin and Product adjusted gross margin increased $51.1 million and $50.9 million, respectively as compared to the nine months ended September 30, 2021. The increases in Product gross margin and Product adjusted gross margin are primarily due to a favorable mix weighted more heavily to higher margin products.

For the three months ended September 30, 2022, Services gross margin and Services adjusted gross margin each increased $46.0 million, as compared to the three months ended September 30, 2021. The increases in Services gross margin and Services adjusted gross margin are primarily due to the impact of the Q3-21 lease revenue reversal for $86.0 million, as a result of the completion of the Company’s arrangement with BARDA in November 2021, partially offset by the cessation of manufacturing activities related to the AstraZeneca and Janssen contracts and a decrease in margins at the Camden facility due to additional investments in quality enhancement and improvement initiatives.

For the nine months ended September 30, 2022, Services gross margin and Services adjusted gross margin each decreased $230.8 million as compared to the nine months ended September 30, 2021. The decreases in 2022 are primarily due to the decline in revenue at the Bayview facility as a result of the completion of the Company’s arrangement with BARDA, the cessation of manufacturing activities related to the AstraZeneca and Janssen contracts, and the decrease in margins at the Camden facility due to additional investments in quality enhancement and improvement initiatives, including an increase in professional services costs.

For Q3 2022, capital expenditures decreased largely due to less spending associated with the expansion project at the Company’s Rockville facility, which has progressed to a less capital intensive phase. The Company anticipates completing this expansion project by year end 2022.

2022 FINANCIAL FORECAST(1)

The Company has updated its full year 2022 financial forecast to reflect management’s expectations based on the most current information available.

The following key assumptions are incorporated into the revised forecast.

Anthrax Vaccines: Reflects anticipated deliveries of AV7909 and BioThrax (Anthrax Vaccine Adsorbed) and the impact of the FDA Warning Letter on certain batches filled/finished at the Camden site.
ACAM2000: Reflects the removal of revenues associated with the next option exercise under the existing 10-year BARDA procurement contract, as the timing is now uncertain.
TEMBEXA: Reflects the initial revenues related to deliveries under the existing 10-year HHS procurement contract and following the September 2022 acquisition from Chimerix of its worldwide rights to this product.
Nasal Naloxone Products: Primarily reflects continued strong demand in the public interest (PIP) channel in the U.S. as well as continuing demand in Canada.
CDMO: Reflects the continued rebaselining of the services business overall and, specifically, the impact of reduced production output from the Camden facility following the FDA’s issuance of a Warning Letter for this site earlier in 2022.
FOOTNOTES

(1) All financial information incorporated within this release is unaudited.
(2) See "Reconciliation of Non-GAAP measures" and the reconciliation tables for reconciliations of these non-GAAP metrics to the most closely related GAAP metrics.
(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts in accordance with U.S. generally accepted accounting principles.
(4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.
(5) Other income (expense), net item adjustments to reconcile Net Income (Loss) to Adjusted EBITDA are related to the expense of the release of an indemnified uncertain tax position, which was recorded to other income (expense), net during the three and nine months ended September 30, 2022.
(6) Includes the reversal of the impact of a $58 million inventory step up related to the TEMBEXA asset acquisition which closed during Q3 2022.

CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, November 8, 2022, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following

On November 8, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4957 per share out of the Company’s capital surplus (Press release, Cardinal Health, NOV 8, 2022, View Source [SID1234623414]). The dividend will be payable on January 15, 2023 to shareholders of record at the close of business on January 3, 2023.

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On November 8, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the third quarter 2022, recent business highlights, and key upcoming catalysts (Press release, Atara Biotherapeutics, NOV 8, 2022, View Source [SID1234623413]).

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"Receiving the positive CHMP opinion for EbvalloTM (tabelecleucel) positions our product to be the first-ever approved allogeneic off-the-shelf T-cell therapy and provides important validation for our EBV T-cell platform and portfolio," said Pascal Touchon, President and Chief Executive Officer of Atara. "We continue to generate positive forward momentum across our programs, punctuated by compelling new biomarker imaging and long-term clinical data that further reinforce our belief in the transformative potential of ATA188."

Tabelecleucel (tab-cel or EbvalloTM) for EBV-Associated Ultra-Rare Cancers

Atara received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for EbvalloTM as a monotherapy for treatment of adult and pediatric patients two years of age and older with relapsed or refractory Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD)
With CHMP positive opinion, the European Commission’s (EC) potential approval of the EbvalloTM Marketing Authorization Application (MAA) is expected by the end of 2022
Atara recently held a meeting with the U.S. Food and Drug Administration (FDA) that culminated in clear guidance and agreement on specific chemistry, manufacturing, and controls (CMC) Module 3 requirements for potential biologics license application (BLA) submission
A new meeting is planned with the FDA to discuss and potentially align on clinical data package requirements to prepare for a pre-BLA meeting
Atara will present updated interim analysis and safety results of the Phase 3 ALLELE study in relapsed/refractory (r/r) EBV+ PTLD with additional patients and longer follow up at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
Consistent with the transformative potential of tab-cel in EBV+ PTLD, overall ORR was 51.2% (22/43, 95% CI: 35.5, 66.7), 50% (7/14, 95% CI: 23.0, 77.0) in HCT, and 51.7% (15/29, 95% CI: 32.5, 70.6) in SOT with median TTR of 1.0 month and median duration of response (DOR) of 23 months
Overall median OS was 18.4 months (95% CI: 6.9, NE), with patients who responded having longer survival versus non-responders
Additionally, Atara will present updated efficacy and safety data from two single-center, open-label studies and a multicenter expanded access program in patients with EBV+ leiomyosarcomas (EBV+ LMS), who have received at least one therapy at the ASH (Free ASH Whitepaper) Annual Meeting
Clinical benefit rate (CR, PR, SD) was 77.8% (95% CI: 56.6, 96.2), with objective response rate of 22.2% (95% CI: 6.4, 47.6); the estimated median OS (95% CI) was 77.4 months (18.0, NE)
The safety profile of tab-cel remains consistent with previously reported data with no reports of tumor flare reaction, cytokine release syndrome, transmission of infectious diseases, graft-versus-host disease, or infusion reaction related to treatment
Atara continues to seek a partner for potential U.S. commercialization
ATA188 for Progressive Multiple Sclerosis (MS)

MS is a debilitating disease affecting millions, with limited treatment options and high unmet medical need in progressive forms
Atara presented new magnetic resonance imaging (MRI) biomarker imaging and open-label extension (OLE) clinical data from the Phase 1 study of ATA188 in progressive MS at the 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference
New MRI biomarker imaging data suggest patients who achieved confirmed disability improvement (CDI) demonstrated significantly less brain atrophy over time and increased nMTR in unenhancing lesions. These data support that brain structural changes, including potential remyelination, may underlie durable CDI associated with ATA188
Updated results from the ongoing OLE with up to 46 months total follow up in patients achieving CDI demonstrate durability of improvement once achieved. Patients with stable disease, meaning no decline in EDSS, have maintained stability for up to four years
Based on enrollment in the Phase 2 EMBOLD study at the end of July, approximately 90 patients are planned to be included in the read out of the study primary endpoint of confirmed disability improvement of EDSS at 12 months. Communication of these data is planned to occur in October 2023
CAR T Programs

ATA2271 (Solid Tumors Over-Expressing Mesothelin)

The ongoing Phase 1, Memorial Sloan Kettering Cancer Center (MSK)-conducted, and investigator led clinical study of autologous mesothelin chimeric antigen receptor (CAR) T-cell therapy, ATA2271, has resumed after a voluntary pause in enrollment earlier this year
Details on the latest findings, including clinical and safety observations, will be presented at a session titled, "Building on CAR-T Experience in Mesothelioma," at ESMO (Free ESMO Whitepaper) Immuno-Oncology on December 7, 2022
ATA3219 (B-cell Malignancies)

ATA3219 is a potential best in class off-the-shelf allogeneic CD19 program using an optimized approach to address high unmet medical need. Leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform, ATA3219 does not require TCR or human leukocyte antigen (HLA) gene editing
The ATA3219 manufacturing process optimization is progressing to ensure appropriate scale-up. Atara anticipates filing an IND in Q2 2023 following completion of process optimization and manufacturing runs in the GMP manufacturing suites of our strategic manufacturing partner, FUJIFILM Diosynth Biotechnologies
Third Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2022 totaled $265.4 million, as compared to $331.3 million as of June 30, 2022
In September 2022, Atara announced an additional near-term milestone payment under an updated tabelecleucel commercialization agreement with Pierre Fabre. Under this agreement, Atara will receive an additional $30 million upon EC approval and subsequent filing of the MAA transfer to Pierre Fabre
Atara believes that its cash and investments as of September 30, 2022, together with potential cash inflows from Pierre Fabre and the expected reductions in operating cash burn, will be sufficient to fund the Company’s planned operations into Q1 2024
Net cash used in operating activities was $65.1 million for the third quarter 2022, as compared to $59.0 million for the same period in 2021
Atara reported a net loss of $84.1 million, or $0.82 per share, for the third quarter 2022, as compared to a net loss of $84.7 million, or $0.90 per share, for the same period in 2021
License and collaboration revenue was $4.5 million for the third quarter 2022, primarily consisting of revenue recognized due to the termination of the Bayer agreements, as compared to $5.4 million for the same period in 2021.
Total operating expenses include non-cash expenses of $15.4 million for the third quarter 2022, as compared to $16.0 million for the same period in 2021
Research and development expenses were $70.2 million for the third quarter 2022, as compared to $70.3 million for the same period in 2021
Research and development expenses include $8.0 million of non-cash stock-based compensation expenses for the third quarter 2022 as compared to $7.8 million for the same period in 2021
General and administrative expenses were $18.9 million for the third quarter 2022, as compared to $19.8 million for the same period in 2021
General and administrative expenses include $6.0 million of non-cash stock-based compensation expenses for the third quarter 2022, as compared to $5.9 million for the same period in 2021
Conference Call and Webcast Details

Atara will host a live conference call and webcast today, Tuesday, November 8, 2022, at 4:30 p.m. EDT to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13733805. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived replay will be available on the Company’s website for 30 days following the live webcast.

On November 8, 2022 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the third quarter ended September 30, 2022 (Press release, Novavax, NOV 8, 2022, View Source [SID1234623412]).

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"Our progress in the third quarter continued as we successfully expanded our COVID-19 vaccine’s label, achieved policy recommendations globally and expanded our body of clinical evidence supporting the differentiated benefit of our vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "New data that we announced today reaffirms the broad immune responses of NVX-CoV2373 against circulating variants. Additionally, based on our most recent Phase 1/2 trial results for our COVID-19-Influenza Combination (CIC) vaccine candidate, we look forward to initiating our Phase 2 clinical trial by the end of this year."

Third Quarter 2022 and Recent Highlights

Expanded COVID-19 Vaccine in Adult Population Aged 18 and Older

Nuvaxovid booster authorized for emergency use in the U.S., European Union (EU), Switzerland, United Arab Emirates (UAE) and New Zealand, with submissions completed to World Health Organization (WHO), as well as in Great Britain and South Korea
Recommendations provided by U.S. Centers for Disease Control and Prevention (CDC), E.U.’s Committee for Medicinal Products for Human Use and Switzerland’s Federal Office of Public Health

Nuvaxovid granted import and use permit in Israel for primary series and as a booster

Covovax granted full product registration in South Africa for primary series
Expanded COVID-19 Vaccine in Adolescent Population Aged 12 Through 17

Nuvaxovid primary series authorized for emergency use in the U.S., EU, Japan, Great Britain, Australia, South Korea, Taiwan, Switzerland, Thailand, UAE and New Zealand, with submissions completed to WHO and in Singapore
Recommendation provided by U.S. CDC

Nuvaxovid granted import and use permit in Israel for primary series and as a booster
COVID-19 Vaccine Manufacturing and Supply

Delivered over 94 million doses of NVX-CoV2373 globally to date

Completed submission to add Novavax Czech Republic as an EU manufacturing site

Solidified manufacturing and supply network ensuring capacity to support ongoing global demand
COVID-19 Clinical Development Program

Announced topline results from Phase 3 Boosting Trial for Omicron BA.1 vaccine candidate (NVX-CoV2515), meeting the primary strain-change endpoint and reaffirming that prototype vaccine induces broadly cross-reactive responses, suggesting utility against current and future variants

PREVENT-19 Phase 3 NVX-CoV2373 homologous booster data support benefits against variants
Following a single homologous booster dose, adult participants demonstrated increased anti-spike IgG levels and increased functional antibody levels measured by hACE2 receptor inhibition against Omicron BA.1, BA.2 and BA.5 variants, approximating levels observed in our Phase 3 efficacy studies
Robust booster responses were consistent between younger (less than 65 years of age) and older (greater than 65 years of age) adults, and independent of whether the booster dose was administered eight or 11 months after the primary series, offering further evidence of broad utility and duration of response with NVX-CoV2373
Adolescent participants following a single booster dose demonstrated neutralizing titers were 2.7-fold higher than those seen with primary vaccination and a broad antibody response against Omicron BA.1, BA.2 and BA.5 variants

Demonstrated NVX-CoV2373 induced consistent immune responses when boosted on top of mRNA or AD26 vaccines, and achieved primary endpoint of Lot Consistency study for adults aged 18 through 49, demonstrating a consistent manufacturing process
When used as a heterologous boost (after either 2 or 3 doses of mRNA OR 1 or 2 doses of AD26) NVX-CoV2373 generated antibody levels previously found to be related to efficacy in the PREVENT-19 Phase 3 trial

Initiated Phase 2b/3 Hummingbird global clinical trial for NVX-CoV2373 in younger children aged six months through 11 years, enrolling the sentinel cohort in the first group aged six through 11 years in the U.S.
Based on initial supportive safety and tolerability data analyzed by an independent Safety and Monitoring Committee, progressed to recruiting the full age cohort
COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development

Announced positive cellular immunity results of CIC Phase 1/2 trial following initial results announced in April, demonstrating ability to generate immune responses, including both antibody and polyfunctional CD4+ T-cell responses, against SARS-CoV-2 and homologous and heterologous influenza strains
Generated robust antibody responses against both prototype and Omicron BA.1 strains of SARS-CoV-2 and influenza antigens
Safety and tolerability profile was consistent with standalone NVX-CoV2373 prototype vaccine and quadrivalent influenza vaccine candidate
Phase 2 trial expected to begin by the end of 2022
Corporate Highlights

Strengthened corporate leadership with appointment of a new board member and executive promotions
Rick Rodgers appointed to Board of Directors
Silvia Taylor promoted to Executive Vice President, Chief Communications Officer
Henrietta Ukwu, M.D. promoted to Executive Vice President, Chief Regulatory Officer
Financial Results for the Three Months Ended September 30, 2022

Total revenue for the third quarter of 2022 was $735 million, compared to $179 million for the comparable period in 2021. Third quarter of 2022 total revenue includes $628 million of revenue comprised of $626 million of product sales from NVX-CoV2373 based on the sale of 35 million doses sold by Novavax and $2 million of royalties, milestone and adjuvant sales to our license partners. Grant revenue of $106 million in the third quarter of 2022 compared to $135 million in the prior year resulted from a decrease in activity under our agreements with the Coalition for Epidemic Preparedness Innovations.

Cost of sales for the third quarter of 2022 were $435 million. This includes $249 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments under our third-party supply agreements. During 2021 and prior to receipt of regulatory authorizations for NVX-CoV2373, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized to inventory. Cost of sales valued at expected standard costs, including expenses related to excess and obsolete inventory, would have been approximately $444 million.

Research and development expenses for the third quarter of 2022 were $304 million compared to $408 million for the comparable period in 2021. The decrease was primarily the result of a $98 million benefit from the settlement of a manufacturing agreement.

Selling, general and administrative expenses for the third quarter of 2022 were $123 million compared to $78 million for the comparable period in 2021. The increase in the period was the result of activities in support of the commercialization of NVX-CoV2373.

Net loss for the third quarter of 2022 was $169 million compared to a net loss of $322 million for the comparable period in 2021.

Cash, cash equivalents, and restricted cash were $1.3 billion as of September 30, 2022, compared to $1.5 billion as of December 31, 2021.
Financial Guidance

Refining full year 2022 total revenue guidance, to approximately $2.0 billion, the low end of the previous guidance of $2.0 to $2.3 billion. Total revenue reflects all sources, including product sales of Nuvaxovid by Novavax, grants revenue, royalties and other revenue.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (833) 974-2381 (Domestic) or (412) 317-5774 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on November 8, 2022 until 11:59 p.m. ET on November 15, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 3408655.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until February 8, 2023.

Trade Name in the U.S.

The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein and is formulated with Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of the vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’ global supply chain.

About Matrix-M Adjuvant

Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax’ Influenza Program

Novavax’ influenza vaccine, previously known as NanoFlu, is a quadrivalent recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences, and contains Novavax’ patented saponin-based Matrix-M adjuvant. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.

On November 8, 2022 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Protagonist, NOV 8, 2022, View Source [SID1234623411]).

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"Continued execution of the Phase 3 VERIFY global clinical development program of rusfertide in polycythemia vera remains our top corporate priority," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Rusfertide has the potential to transform the current treatment paradigm for PV, dramatically improving patients’ lives. The enthusiasm we have observed around rusfertide, among patients and physicians alike, reinforces our commitment to advancing this important drug candidate as rapidly as possible."

Dr. Patel continued, "We are pleased to have recently announced a new Chief Medical Officer, Dr. Arturo Molina, a renowned hematologist-oncologist and a successful drug developer. Dr. Molina will focus on providing medical and operational leadership to our rusfertide clinical development program.

"Our Janssen-partnered asset, PN-235 (JNJ-77242113), an oral peptide interleukin 23 receptor (IL-23R) antagonist, is currently in multiple Phase 2 clinical studies to assess safety and efficacy in moderate-to-severe plaque psoriasis. We look forward to decision-driving results from these studies in the first half of next year. With important pending readouts for both rusfertide and PN-235, we expect the first half of 2023 to be a period of potential transformational value creation for Protagonist."

Third Quarter 2022 and Recent Developments

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Potential Indications

While significant efforts have been undertaken toward the goal of full enrollment of the Phase 3 VERIFY study, and a high degree of interest has been observed from physician and patient communities, operational challenges including site staff shortages have continued to delay initial recruitment activities. The Company expects enrollment completion in the second half of 2023.
Protagonist will have three poster presentations at the 2022 ASH (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 10-13 in New Orleans, Louisiana. Details are as follows:
Poster Presentation 1:
Title: VERIFY: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I
Session Date: Saturday, December 10, 2022
Presentation Time: 5:30 PM – 7:30 PM CT.
Poster Presentation 2:
Title: Subgroup Analysis of Adverse Events Following Rusfertide Dosing in REVIVE: A Phase 2 Study of Patients with Polycythemia Vera
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM – 8:00 PM CT.
Poster Presentation 3:
Title: Rusfertide Analog-PN23114 as a Hepcidin Mimetic Provides Efficacy Benefits in Conjunction with Phlebotomy in Mouse Model for Hereditary Hemochromatosis
Session Name: 102. Iron Homeostasis and Biology: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM – 8:00 PM CT.
In keeping with the Company’s organizational prioritization of rusfertide in PV, plans to initiate studies of rusfertide in additional disease indications have been paused. This decision was influenced in part by enactment of the Inflation Reduction Act in the U.S. and includes previously planned studies of rusfertide in the subset of hereditary hemochromatosis (HH) patients with chronic arthropathy.
PN-235: Oral IL-23 Receptor Antagonist

Four clinical studies of PN-235 (JNJ-77242113), a drug candidate discovered by Protagonist and further developed in collaboration with Janssen, are underway and led by Janssen:
FRONTIER 1, a Phase 2b multicenter, randomized, placebo controlled, 240-patient dose-ranging study commenced in early 2022 to evaluate the safety and efficacy of PN-235 for the treatment of moderate-to-severe plaque psoriasis;
FRONTIER 2, a long-term extension study in moderate-to-severe plaque psoriasis;
SUMMIT, a study of an oral tablet formulation of PN-235 for the treatment of moderate-to-severe plaque psoriasis; and
A separate Phase 1 study of PN-235 in healthy Japanese and Chinese participants. More information on these studies can be found at View Source
Protagonist expects the results of these studies to inform the next steps for PN-235 development. To date, $112.5 million in development milestones have been received and the Company remains eligible for up to approximately $855.0 million in future development and sales milestones. In the near term, the Company is eligible for a $10 million milestone payment in connection with the start of a second indication-based Phase 2 study, and a $50 million milestone upon dosing of a third patient in a Phase 3 study of PN-235.
PN-943: Oral, Gut-Restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)

With the exception of completing the 40-week extended treatment period for eligible patients in the Phase 2 IDEAL study, expected to be completed in Q1 2023, the Company intends to dedicate no further internal resources to clinical development or CMC activities for PN-943. The Company will continue to explore out-licensing opportunities globally.
Management and Operational Updates

Arturo Molina, M.D., M.S. has joined Protagonist as its Chief Medical Officer (CMO). Dr. Molina’s responsibilities will include strategic and execution leadership across the Company’s clinical development programs, with a primary focus on the Phase 3 VERIFY study of rusfertide in PV.
Dr. Molina comes most recently from Sutro Biopharma, where he was Chief Medical Officer for more than six years. Previously, from 2013 to 2016, Dr. Molina was Vice President, Oncology Scientific Innovation, at Johnson & Johnson.
De-prioritization of the PN-943 program and streamlining of certain discovery programs is part of Company’s ongoing commitment to optimize and focus resources toward the rusfertide program in PV.
Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2022 were $267.4 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the end of 2024.
License and Collaboration Revenue: License and collaboration revenue was zero and $26.6 million for the three and nine months ended September 30, 2022, respectively, as compared to $10.3 million and $18.7 million, respectively, for the same periods in 2021. The decrease in revenue from prior year quarter was primarily due to a decrease in the level of services the Company provided under the Janssen license and collaboration agreement. The Company completed its performance obligation pursuant to the collaboration as of June 30, 2022. The revenue increase from prior year-to-date included the $25.0 million milestone that the Company became eligible to receive in March 2022 upon the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 study of PN-235.
Research and Development ("R&D") Expenses: R&D expenses were $25.4 million and $96.3 million for the three and nine months ended September 30, 2022 as compared to $37.0 million and $87.6 million for the same periods in 2021. The decrease in R&D expense from prior year quarter was primarily due to lower PN-943 expenses related to the suspension of further program expenditures and the impact of $4.0 million recorded during the third quarter of 2021 related to the resolution of the Company’s collaboration agreement dispute with Zealand Pharma. The increase in R&D expense from prior year to date was primarily due to costs associated with rusfertide and PN-943, including current and planned Phase 3 clinical trials, partially offset by a decrease in costs related to the completion of PN-235 and PN-232 Phase 1 trials and the impact of $4.0 million recorded during the third quarter of 2021 related to the resolution of the Company’s collaboration agreement dispute with Zealand Pharma.
General and Administrative ("G&A") Expenses: G&A expenses were $6.9 million and $25.1 million for the three and nine months ended September 30, 2022 as compared to $7.3 million and $19.9 million for the same periods in 2021. The decrease from prior year quarter was primarily due to decreases in consulting, legal and other expenses. The increase from prior year to date was primarily due to increases in personnel related and other expenses to support Company growth.
Net Loss: Net loss was $31.2 million, or $0.64 per share, for the three months ended September 30, 2022 as compared to a net loss of $33.8 million, or $0.70 per share, for the three months ended September 30, 2021. Net loss was $93.2 million, or $1.90 per share, for the nine months ended September 30, 2022 as compared to a net loss of $88.6 million, or $1.94 per share for the nine months ended September 30, 2021.