On February 25, 2021 Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Acceleron Pharma, FEB 25, 2021, View Source [SID1234575641]).

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"2020 was a very productive year for Acceleron as we generated important results in our lead pulmonary program to advance sotatercept into a registrational Phase 3 trial and executed on a successful first full year of the commercial launch of REBLOZYL in the United States," said Habib Dable, President and Chief Executive Officer of Acceleron. "I would like to acknowledge our team’s strong commitment to our company and mission as these important milestones along with many others were achieved despite the many challenges resulting from the ongoing global pandemic. Throughout the year, we presented updates from our two Phase 2 trials with our lead pulmonary program, supporting our long-term vision of establishing sotatercept as a backbone therapy for patients with pulmonary arterial hypertension across all stages of the disease."

Added Mr. Dable: "As we continue to grow our capabilities in rare pulmonary disease, we are also advancing ACE-1334 into a Phase1b/Phase 2 trial in patients with systemic sclerosis-associated interstitial lung disease later this year. We look forward to hosting a research and development day to provide additional details on our long-term vision and programs in rare pulmonary disease in the middle of 2021."

Program Highlights

Pulmonary

Sotatercept: Pulmonary Arterial Hypertension (PAH)

Sotatercept is an investigational reverse-remodeling agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. The PULSAR Phase 2 trial evaluating sotatercept in combination with approved PAH-specific medicines in patients with PAH achieved its primary endpoint of improvement in pulmonary vascular resistance and its key secondary endpoint of improvement in 6-minute walk distance.

In November, the Company presented the 24-week echocardiography results from the PULSAR Phase 2 trial at the virtual 2020 American Heart Association (AHA) Scientific Sessions, which earned the AHA’s "Cardiopulmonary Best Abstract" award. In addition, preliminary interim results from the SPECTRA Phase 2 trial were presented at the congress.
In December, the European Commission (EC) granted Orphan Drug designation to sotatercept for the treatment of patients with PAH.
In December, Acceleron initiated its registrational STELLAR Phase 3 trial in patients with PAH.
The Company expects to initiate the HYPERION (early intervention) Phase 3 trial and the ZENITH (WHO Functional Class IV) Phase 3 trial in expanded PAH populations in the middle of 2021.
Results from the open-label extension period of the PULSAR Phase 2 trial and additional results from the SPECTRA Phase 2 trial are expected in the first half of 2021.
ACE-1334: Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)

ACE-1334 is an Acceleron-discovered, TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands but not TGF-beta 2. ACE-1334 has shown robust anti-fibrotic activity in multiple preclinical models of fibrosis. ACE-1334 recently completed an ascending-dose Phase 1 clinical trial in healthy volunteers.

In December, the United States Food and Drug Administration (FDA) granted Orphan Drug designation to ACE-1334 for the treatment of patients with systemic sclerosis.
Acceleron expects to start a Phase 1b/Phase 2 study to evaluate the activity of ACE-1334 in patients with SSc-ILD in 2021.
Hematology

REBLOZYL (luspatercept-aamt):

REBLOZYL is the first and only approved erythroid maturation agent designed to promote late-stage red blood cell (RBC) production. REBLOZYL is part of the global collaboration between Acceleron and Bristol Myers Squibb.

The Company recognized approximately $23.0 million in royalty revenue from approximately $115 million in net sales of REBLOZYL in the fourth quarter of 2020. This compares with approximately $19.3 million in royalty revenue from approximately $96 million in net sales of REBLOZYL in the third quarter of 2020.
For the full year 2020, Acceleron recognized approximately $54.8 million in royalty revenue from approximately $274 million in net sales of REBLOZYL.
In February 2021, Acceleron and partner Bristol Myers Squibb announced that Health Canada approved REBLOZYL for the treatment of adult patients with transfusion-dependent anemia requiring at least two RBC red blood cell units over 8 weeks resulting from very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy.
Six clinical abstracts on REBLOZYL were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition held virtually in December 2020.
The INDEPENDENCE Phase 3 trial is initiating in patients with myelofibrosis.
The Companies expect to present results from the BEYOND Phase 2 trial in adult patients with non-transfusion-dependent beta-thalassemia in the first half of 2021.
Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with first-line lower-risk MDS, with topline results expected in 2022+.
Corporate Highlights

Acceleron is planning to host a research and development day in the middle of 2021 to provide a deep dive into all of the Company’s programs.
Financial Results

Cash Position – Cash, cash equivalents and investments as of December 31, 2020 were $857.5 million. Based on Acceleron’s current operating plan and projections, the Company believes that its current cash, cash equivalents and investments, along with the expected royalty revenue from REBLOZYL sales, will be sufficient to fund the Company’s projected operating requirements for the foreseeable future.
Revenue – Revenue for the fourth quarter of 2020 was $25.9 million, which includes $2.9 million of cost share revenue and $23.0 million of royalty revenue from net sales of REBLOZYL. Revenue for the full year was $92.5 million, which includes $12.7 million of cost share revenue, $54.8 million of royalty revenue from net sales of REBLOZYL, and the recognition of a $25.0 million regulatory-based milestone for the approval of REBLOZYL in Europe. All revenue was derived from the Company’s partnership with Bristol Myers Squibb.
Costs and Expenses – Total costs and expenses for the fourth quarter of 2020 were $83.5 million. This includes R&D expenses of $57.3 million and SG&A expenses of $26.2 million. Total costs and expenses for the full year were $259.8 million. This includes R&D expenses of $173.9 million and SG&A expenses of $85.9 million.
Net Loss – The Company’s net loss for the fourth quarter of 2020 was $57.4 million. The Company’s net loss for the year ended December 31, 2020 was $166.0 million.
Conference Call and Webcast

The Company will host a webcast and conference call to discuss its fourth quarter and full year 2020 financial results on February 25, 2021, at 5:00 p.m. EST.

The webcast will be accessible under "Events & Presentations" in the Investors & Media page of the Company’s website at www.acceleronpharma.com. To participate in the conference call, please dial 833-494-1483 (domestic) or 236-714-2620 (international) and reference code #4282162.

An archived version of the webcast will be available for replay on the Company’s website for approximately one year.

On February 25, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Tracon Pharmaceuticals, FEB 25, 2021, View Source [SID1234575640]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We ended 2020 on a high note by enrolling the first patient in the ENVASARC pivotal trial within one year of licensing envafolimab and raising additional capital at market price that further extends our cash runway into the second half of 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We are focused on enrolling the ENVASARC trial expeditiously and expect the availability of interim data later this year, final data in 2022, and assuming positive clinical data and regulatory approval, to potentially commercialize envafolimab in 2023, in order to address a high unmet need for patients with UPS or MFS."

Recent Corporate Highlights

Envafolimab

As of February 5, 2021, TRACON had initiated 16 clinical sites and enrolled multiple patients at multiple sites in the pivotal ENVASARC trial of single agent envafolimab and envafolimab combined with Yervoy.

In January 2021, TRACON announced that its partners Alphamab Oncology and 3D Medicines received notification their New Drug Application for envafolimab, submitted in November 2020 in China, was granted priority review by the Center for Drug Evaluation of the National Medical Products Administration in the indication of MSI-H/dMMR cancer.

In December 2020, TRACON announced the dosing of the first patient in the pivotal ENVASARC trial.
TRC102

In November 2020, TRACON announced the publication of clinical data in the journal Cancer Cell, that provided molecular insight into TRC102’s mechanism of action and patient populations most likely to respond to treatment. The article, entitled, "Molecular Features of Cancers Exhibiting Exceptional Responses to Treatment," highlighted the clinical features and tumor biology of an exceptional responder patient treated with TRC102. TRC102 is a small molecule inhibitor of DNA base inhibitor repair being studied in Phase 1 and Phase 2 trials sponsored by the National Cancer Institute.
Corporate

In December 2020, TRACON announced financings of approximately $13.8 million in the aggregate with multiple new and existing healthcare focused institutional investors through registered direct offerings of its common stock. The financings were completed at market price, and TRACON expects the net proceeds will extend its cash runway into the second half of 2022.
Expected Key Upcoming Milestones

Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021.

Submit envafolimab response data to the FDA for orphan drug designation in sarcoma in 1H 2021.

Data presentation on TJ004309 Phase 1 results in 1H 2021.

Interim ENVASARC efficacy and safety data in 2H 2021.

Data presentation on TRC102 Phase 2 results in 2H 2021.

Request FDA breakthrough therapy designation for envafolimab in 2H 2021.

Decision on envafolimab NDA in China for MSI-H/dMMR cancer.
Fourth Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments were $36.1 million at December 31, 2020, compared to $16.4 million at December 31, 2019. The Company expects that its current cash, cash equivalents and short-term investments will fund operations into the second half of 2022.

Research and development expenses for the fourth quarter of 2020 were $2.2 million, compared to $1.9 million for the fourth quarter of 2019.

General and administrative expenses for the fourth quarter of 2020 were $2.0 million, compared to $1.9 million for the fourth quarter of 2019.

Net loss for the fourth quarter of 2020 was $4.3 million, compared to $4.0 million for the fourth quarter of 2019.
Conference Call Details

Thursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 5681569
A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the US FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On February 25, 2021 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Apollo Endosurgery, FEB 25, 2021, View Source [SID1234575639]). The Company will hold a conference call today at 3:30 p.m. CT / 4:30 p.m. ET to discuss its results.

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Highlights
•Fourth quarter U.S. Endoscopy product sales increased 14.9%
•Net operating loss in the fourth quarter was $3.2 million, a 53.0% reduction from the $6.9 million net operating loss in the fourth quarter of 2019
•Operations used $2.8 million of cash in the fourth quarter of 2020, a 58.1% improvement compared to $6.7 million used in the fourth quarter of 2019
•Received FDA clearance for the X-Tack Endoscopic HeliX Tacking system
Todd Newton, CEO of Apollo, said, "Our revenue in the fourth quarter reflected a continuing recovery of US market procedure volumes. This recovery combined with our cost reduction efforts resulted in a pronounced improvement in our profitability and cash utilization in the fourth quarter, providing a solid foundation as we transition leadership to Apollo’s next CEO, Chas McKhann."
"In addition the 510k clearance of our X-Tack Endoscopic HeliX Tacking System in December adds a new product to our portfolio and opens for our suturing franchise a new and significant addressable market in the lower gastrointestinal tract," said Newton. "With over 20 million lower gastrointestinal tract endoscopic procedures performed annually in the U.S., X-Tack fulfills a long-expressed need for a readily-available advanced closure device to improve healing and reduce adverse event risks."
Total worldwide revenue increased 7.3% to $12.9 million in the fourth quarter of 2020 compared to the fourth quarter of 2019.
ESS product sales increased $0.2 million, or 2.3% in the fourth quarter of 2020 compared to 2019. Fourth quarter U.S. ESS product sales increased 10.2% while OUS ESS product sales decreased 9.3% due to a reduction in European direct market procedures following resurgent COVID-19 concerns during the quarter.
IGB product sales increased 7.1% during the fourth quarter 2020 compared to the fourth quarter 2019. In the U.S., IGB product sales increased 32.7% while OUS IGB product sales decreased 2.4%.
Gross margin for the fourth quarter of 2020 was 55.9%, compared to 48.7% for the fourth quarter of 2019 due to continued progress on the Company’s gross margin improvement projects, higher overhead absorption in the fourth quarter of 2020 due to increased inventory production, and an increase in direct market IGB sales as a percentage of total revenue.
Total operating expenses decreased $2.3 million to $10.4 million for the fourth quarter of 2020 compared to the same period of 2019. This reduction was the result of the operating cost restructuring completed earlier in 2020.
Net loss for the fourth quarter of 2020 was $3.5 million compared to $7.2 million for the fourth quarter 2019.
Cash, cash equivalents and restricted cash were $37.2 million as of December 31, 2020.
In December 2020, the Company entered into an agreement with Solar Capital Ltd. to extend the interest only period and maturity date of its existing term loan by 12 months, improving the Company’s 2021 liquidity by approximately $12.0 million. The amendment will further extend the interest only period and term by an additional 6 months if 2021 revenue milestones are achieved.
Conference Call
Apollo will host a conference call on February 25, 2021 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the fourth quarter and year ended December 31, 2020. To join the conference call dial +1 973-528-0011. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: ir.apolloendo.com.
A replay of the webcast will remain available on Apollo’s website, www.apolloendo.com, following the call.

Non-GAAP Financial Measures
To supplement our financial results, we are providing a non-GAAP financial measure, Endoscopy product sales percentage change in constant currency, which removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of revenues compared to the same period of the prior year. Endoscopy product sales percentage change in constant currency is calculated by translating current foreign currency sales at last year’s exchange rate. This supplemental measure of our performance is not required by, and is not determined in accordance with GAAP.
We believe the non-GAAP financial measure included herein is helpful in understanding our current financial performance. We use this supplemental non-GAAP financial measure internally to understand, manage and evaluate our business, and make operating decisions. We believe that making non-GAAP financial information available to investors, in addition to GAAP financial information, may facilitate more consistent comparisons between the company’s performance over time with the performance of other companies in the medical device industry, which may use similar financial measures to supplement their GAAP financial information. However, our non-GAAP financial measure is not meant to be considered in isolation or as a substitute for the comparable GAAP metric.

On February 25, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the fourth quarter and full year 2020 (Press release, Dynavax Technologies, FEB 25, 2021, View Source [SID1234575638]).

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"2020 was an important year for Dynavax as we continue to build a leading vaccine company underpinned by growing recurring revenue from both HEPLISAV-B and CpG 1018," commented Ryan Spencer, Chief Executive Officer of Dynavax. "In addition to HEPLISAV-B, we continue to progress numerous collaborations to develop our proven vaccine adjuvant CpG 1018 across multiple indications, including COVID–19, pertussis, and universal flu."

Mr. Spencer added, "Our COVID-19 collaborations have advanced significantly in recent months with multiple partners targeting emergency use authorization in the second half of 2021. The emerging portfolio of product opportunities with CpG 1018 has the potential to drive significant revenue growth in 2021 and beyond. Through the continued advancement of our multiple collaborations, CpG 1018 could be utilized in up to 500 million to 1.5 billion doses of vaccine annually starting in 2022, with additional capacity expansion available depending on global demand."

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Full year 2020 net product revenue of $36.0 million compared to $34.6 million for full year 2019, a 4% year-over-year growth rate despite the substantial ongoing reduction in market utilization due to the pandemic and COVID-19 vaccine rollout.
Net product revenue for HEPLISAV-B during the fourth quarter 2020 was $11.5 million, up 8.5% year-over-year from $10.6 million for the fourth quarter of 2019.
Market share in accounts targeted by the field sales team increased to 26%, up from 20% market share in the fourth quarter of 2019.
Received Marketing Authorization in February 2021 from the European Commission following the positive opinion in December 2020 from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Reported final immunogenicity data from a study in adults with end-stage renal disease (ESRD) undergoing hemodialysis. In this study of 119 patients, HEPLISAV-B demonstrated a high seroprotection rate of 89.3% at week 20 after 4 standard doses.
CpG 1018 (ADVANCED VACCINE ADJUVANT)

Dynavax is scheduled to supply CpG 1018 to produce up to 100 million doses of Valneva’s SE adjuvanted COVID-19 vaccine in 2021, which would generate CpG 1018 revenue of up to $230 million in 2021, contingent on the continued success of Valneva’s vaccine candidate.
First quarter 2021 CpG revenue is anticipated to be between $40 million and $60 million.
Clover Biopharmaceuticals is initiating a global Phase 2/3 efficacy trial with their protein sub–unit COVID-19 vaccine candidate adjuvanted with CpG 1018 with an interim analysis for vaccine efficacy expected in the middle of 2021.
Coalition for Epidemic Preparedness Innovations (CEPI) agreed to provide funding of up to $99 million for advanced manufacturing of CpG 1018 for use in COVID–19 vaccines developed by CEPI grantees to ensure product availability in 2021 upon emergency use authorization.
Dynavax dosed the first participant in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018.
ADDITIONAL CORPORATE UPDATES

Appointed Kelly MacDonald as Senior Vice President and Chief Financial Officer
Dong Yu, Ph.D., joined as Senior Vice President of Vaccine Research
2021 MILESTONES

Publication of data from the study of HEPLISAV-B in patients on hemodialysis anticipated in the first half
Multiple data readouts from our CpG 1018 collaboration partners throughout the year
Final report for HEPLISAV-B post-marketing study expected in the second quarter
Data from the ongoing Phase 1 study of an improved Tdap vaccine candidate adjuvanted with CpG 1018 anticipated in the fourth quarter
Launch HEPLISAV-B in the EU in the fourth quarter
FINANCIAL RESULTS

Total Revenues and Product Revenue, Net. Total revenues for the fourth quarter of 2020 were $19.6 million, including $13.1 million of net product revenue. Total revenues for 2020 were $46.6 million compared to $35.2 million for 2019. HEPLISAV-B product revenue, net increased to $11.5 million in the fourth quarter of 2020 compared to $10.6 million in the same period in 2019. Full year product revenue, net for HEPLISAV-B in 2020 was $36.0 million compared to $34.6 million for the full year 2019. CpG 1018 product revenue, net was $1.6 million in the fourth quarter of 2020 compared to $0.0 million in the same period in 2019. Full year product revenue, net for CpG 1018 in 2020 was $3.3 million compared to $0.0 million for the full year 2019.

Cost of Sales – Product. Cost of sales – product for the fourth quarter 2020 increased to $4.1 million, compared to $2.4 million for the fourth quarter of 2019. Full year 2020 cost of sales – product was $11.4 million compared to $10.2 million for the full year 2019. The increase was primarily due to higher unit costs for HEPLISAV-B as we produce and then sell inventory that reflects the full cost of manufacturing. For the six months ended December 31, 2020, cost of sales-product included $1.4 million of costs to produce CpG 1018 for our collaboration partners. The Company anticipates cost of sales – product to increase substantially in 2021 due to increased manufacturing of CpG 1018 under the supply agreement with Valneva.

Research and Development Expenses. Research and development (R&D) expenses for the fourth quarter of 2020 decreased to $9.5 million, compared to $12.3 million for the fourth quarter of 2019. Full year 2020 R&D expenses were $28.6 million compared to $62.3 million for the full year 2019. The decrease in R&D expenses is due to personnel costs, facilities overhead cost allocations and non-cash stock-based compensation decreases due to lower R&D headcount resulting from our restructuring in May 2019 and the winding down of our immuno-oncology programs and an increase of additional CpG 1018 development costs at our third-party manufacturing facility to support increased CpG 1018 demand from our collaboration partners for use in their development and/or commercialization of COVID-19 vaccines.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the fourth quarter of 2020 decreased to $17.8 million, compared to $20.3 million for the fourth quarter of 2019. Full year 2020 SG&A expenses were $79.3 million compared to $75.0 million for the full year 2019.

Loss from Operations and Net Income Loss. Loss from operations for the fourth quarter of 2020 decreased to $11.9 million from $27.4 million in the fourth quarter of 2019. Full year 2020 loss from operations decreased to $68.4 million compared to $134.8 million for the full year 2019. Net loss for the fourth quarter of 2020 was $15.5 million compared to a net loss of $36.8 million for the fourth quarter of 2019. Basic and diluted net loss per share was $0.14 for the fourth quarter of 2020, compared to $0.44 per basic and diluted net loss per share in the fourth quarter of 2019. Full year 2020 net loss decreased to $75.2 million or $0.75 per basic and $0.78 per diluted share compared to $152.6 million or $2.16 per basic and diluted share for the full year 2019.

Cash Position. Cash, cash equivalents and marketable securities totaled $165.0 million at December 31, 2020.

CONFERENCE CALL AND WEBCAST INFORMATION

Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 8380559. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About CpG 1018

CpG 1018 is the adjuvant used in HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

On February 25, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Personalis, FEB 25, 2021, View Source [SID1234575637]).

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Fourth Quarter Highlights

Record quarterly revenue of $20.2 million in the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, an 11% increase
Record quarterly revenue of $7.6 million from biopharma and all other customers, excluding VA MVP, in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
Launched new neoantigen prediction capabilities (called SHERPA and NEOPS) in the fourth quarter of 2020
"I’m proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and was a record high as some customers pushed to complete projects before the end of the year," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera that further validates our NeXT platform as a best-in-class tissue-sequencing front end, capable of detecting mutations in cancer that conventional exomes often miss. It also complements our whole exome liquid biopsy offering that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct areas in the rapidly growing cancer monitoring market."

Fourth Quarter 2020 Financial Results

Revenues were $20.2 million in the three months ended December 31, 2020, up 11% from $18.2 million in the same period of the prior year.

Gross margin was 30.1% in the three months ended December 31, 2020, compared with 36.2% in the same period of the prior year.

Operating expenses were $19.4 million in the three months ended December 31, 2020, compared with $13.8 million in the same period of the prior year.

Net loss was $13.3 million in the three months ended December 31, 2020 and net loss per share was $0.34 based on a weighted-average basic and diluted share count of 39.0 million, compared with a net loss of $6.6 million and a net loss per share of $0.21 on a weighted-average basic and diluted share count of 31.2 million in the same period of the prior year.

Cash, cash equivalents, and short-term investments were $203.3 million as of December 31, 2020.

Full Year 2020 Financial Results

Revenues were $78.6 million for the year ended December 31, 2020, up 21% from $65.2 million in 2019.

Gross margin was 25.6% for the year ended December 31, 2020, compared with 33.9% in 2019.

Operating expenses were $62.3 million for the year ended December 31, 2020, compared with $44.5 million in 2019.

Net loss was $41.3 million for the year ended December 31, 2020 and net loss per share was $1.20 based on a weighted-average basic and diluted share count of 34.4 million, compared with a net loss of $25.1 million and a net loss per share of $1.39 on a weighted-average basic and diluted share count of 18.0 million in 2019.

First Quarter 2021 Outlook

Personalis expects the following for the first quarter of 2021:

Total Company revenues are expected to be approximately $20.3 million
Revenues from biopharma and all other customers, excluding VA MVP, are expected to be in the range of $5.6 million to $7.0 million
Net Loss is expected to be in the range of $14.0 million to $15.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at View Source