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PharmaMar Group reports 2022 annual results

On February 28, 2023 PharmaMar (MSE:PHM) reported today total revenues of €196 million in 2022, compared with €229 million in the previous year (Press release, PharmaMar, FEB 28, 2023, View Source [SID1234627872]). This difference is mainly due to the non-recurring revenues recorded in 2021 and, to a lesser extent, to the change in regulations in France governing the prices of drugs made available through the compassionate access authorization (L’autorisation d’accès compassionnel, AAC) system. Of the total revenues generated by the Company, 92% originated outside of Spain.

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Of the total revenues recorded in 2022, recurring revenues (sales plus royalties), total €156.0 million compared with €164.8 million recorded in 2021.

Of the total recurring revenues in 2022, royalty revenues and raw material sales to our partners grew. Regarding the former, royalties increased 23% during 2022 to €50.3 million driven by sales of Zepzelca (lurbinectedin) in the US through our partner, Jazz Pharmaceuticals, reaching €46.9 million[1] (€38.0 million in 2021). Raw material sales of both Yondelis (trabectedin) and Zepzelca increased by 11.6% to €21.4 million at year-end.

The 5% period-over-period difference in total recurring revenues is mainly due to the change in revenues from Zepzelca in Europe under the compassionate access program and, to a lesser extent, the decrease in revenues from Yondelis sales as a result of the entry of generic products in the market in the last quarter of the year.

Revenues under the compassionate access program totaled €15.5 million at December 31st, 2022, compared with €30.2 million in 2021. It should be noted that this amount includes the impact of the entering into force in France of the regulations governing the prices of compounds available under the compassionate access authorization (L’autorisation d’accès compassionnel, AAC) system, under which lurbinectedin is distributed in that territory, and which has led to the application of significant discounts from the beginning of 2022.

Net sales of Yondelis amounted to €63.8 million through December 31st, compared with €69.4 million in the previous year. Although gross sales of Yondelis in Europe increased by 2% in 2022, price pressure, as a result of the entry of generic products into the European market is responsible for the 8% difference in net sales.

The Group’s non-recurring revenues, which are those from licensing agreements, totaled €40.2 million at year-end 2022, compared to €64.8 million at December 2021. In 2022, this revenue mainly corresponds to the income of €10 million in relation to Yondelis for the fulfillment of a commercial milestone, under the licensing agreement signed with Janssen (Johnson & Johnson) in 2001, and to the recognition in income of amounts received in 2020 as a result of the lurbinectedin licensing agreement with Jazz Pharmaceuticals ($300 million), amounts that are being recognized in the income statement depending on the degree of progress of the contractual commitments.

At December 31st, 2022, PharmaMar Group’s R&D expenditure amounted to €83.4 million, up 16% with respect to the previous year. This increase is due to the progression in the development of the different research areas. Thus, the oncology area accounted for the largest investment, with a total of €68.1 million, 12% more than in 2021. In 2022, the Company has launched up to 4 Phase III trials in the different therapeutic areas, including the LAGOON trial, which is the registration trial with Zepzelca for the treatment of relapsed Small Cell Lung Cancer. A new marine-derived anti-tumor compound, PM534, entered the clinic in 2022.

In 2022, R&D investment in the area of interfering RNAi also increased to €13 million, compared to €9.5 million in the previous year, as a result of the two phases III trials underway for the treatment of Dry Eye. In addition, a Phase II for the treatment of macular degeneration, among other developments, was initiated in this business area.

At the end of 2022, the PharmaMar Group had generated €38.3 million in cash from operating activities and had reduced total debt to €39 million. As a result, at December 31st, 2022, the group’s cash and cash equivalents position stood at €231.8 million, compared with €212.6 million at the end of the previous year, and net cash amounted to €192.8 million, 15% higher than at the beginning of the year.

On September 27th, the Board of Directors of PharmaMar Group decided to cease the activity of the diagnostics area, which was carried out through its wholly-owned subsidiary Genomica, S.A.U. Consequently, it agreed to initiate the corresponding procedures for the dissolution and liquidation of Genomica, S.A.U.

The PharmaMar Group will close 2022 with a net profit of €49.3 million as a result.

The Board of Directors of PharmaMar Group will propose to the Shareholders’ Meeting that a dividend of €0.65 gross per Pharma Mar, S.A. share be paid to shareholders against 2022 earnings.

Cassava Sciences Reports Full-year 2022 Financial Results and Operating Updates

On February 28, 2023 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the year ended December 31, 2022, and provided operating updates. Simufilam is Cassava Sciences’ oral drug candidate for the proposed treatment of Alzheimer’s disease dementia (Press release, Pain Therapeutics, FEB 28, 2023, View Source [SID1234627871]).

"Setting aside headwinds, 2022 was highlighted by positive developments with patient enrollment in our Phase 3 clinical studies of simufilam in Alzheimer’s disease", said Remi Barbier, President & CEO. "Over 1,000 patients with Alzheimer’s are now enrolled in these two studies. By year-end 2023, we expect to reach our enrollment target of approximately 1,750 patients for the Phase 3 studies. Recently, we announced top-line results for an open-label study. In this study, over 200 mild-to-moderate Alzheimer’s patients were treated with simufilam for a year. Simufilam was well-tolerated, 47% of patients improved on ADAS-Cog scores over 12 months and an additional 23% of patients declined less than 5 points on ADAS-Cog. I believe these are noteworthy trial results, even as I am keenly aware that the gold standard in Alzheimer’s research requires results from randomized, controlled studies."

Alzheimer’s disease is a major public health issue. It imposes an immense burden on patients, their families and caregivers. Anti-amyloid antibody drugs that have received FDA approval are a step in the right direction. But by themselves, anti-amyloid drugs may not be enough for patients. Anti-amyloid drugs can slow cognitive decline modestly, but they can also cause brain bleeds in elderly patients, they require monthly trips to the local infusion center and periodical monitoring with MRI, they’re expensive and they lack Medicare coverage because they bypassed the full FDA approval process. Patients have waited many years for anti-amyloid drugs to be FDA-approved. Now that the wait is over, Cassava Sciences sees an even greater need to develop the next generation of innovative treatments, even if some of these potential treatments challenge scientific orthodoxy.

"It’s the spirit of innovation and our intense desire to help patients and their families that fuels our drive to develop simufilam as an oral drug candidate for people with Alzheimer’s disease," said Remi Barbier.

Cassava Sciences’ Scientific Goals for 2023

In Q2 2023, we expect to complete patient dosing for our on-going Cognition Maintenance Study, in which over 100 patients with mild-to-moderate Alzheimer’s disease are randomized (1:1) to simufilam or placebo for six months.
In Q3 2023, we expect to announce top-line results of the Cognition Maintenance Study.
In Q4 2023, we expect to complete patient enrollment for both of our Phase 3 studies.
Mid-year 2023, we expect an independent, third party to present evidential data for the biological activity of simufilam outside the field of neurodegeneration.
Mid-year 2023, we expect an independent, third party to generate new data for SavaDx using mass spectrometry.
Financial Highlights

At December 31, 2022, cash and cash equivalents were $201 million, compared to $233.4 million at December 31, 2021, with no debt. Year-end cash balance included net proceeds of $47.3 million from the sale of 1.7 million shares of common stock completed in November 2022.
Net cash used in operations full-year 2022 was $77.5 million, net of reimbursements received from National Institutes of Health (NIH) grant awards.
Net cash use for operations for the first half of 2023 is expected to be approximately $45 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.
Research and development (R&D) expenses for the year ended December 31, 2022 were $68.0 million compared to $24.8 million for the same period in 2021. This increase was due primarily to costs to conduct the ongoing Phase 3 clinical program in simufilam, costs of an ongoing cognition maintenance study and open-label study in simufilam, and costs related to manufacture of clinical trial supplies, as well as increased pre-clinical study and personnel expenses compared to the prior year. These expenses are net of grant funding received from NIH, which is recorded as a reduction in R&D expenses.
Research grant funding reimbursements of $0.9 million were received from NIH and recorded as a reduction in R&D expenses. This compared to $3.9 million of NIH grant receipts received for 2021.
General and administrative (G&A) expenses for the year ended December 31, 2022 were $12.0 million compared to $8.1 million for 2021. This increase was primarily due to higher legal fees, personnel costs, insurance costs and depreciation and amortization as compared to 2021.
Ongoing Phase 3 Studies with Simufilam
Cassava Sciences is currently evaluating simufilam tablets for Alzheimer’s disease dementia in two Phase 3 clinical studies. These are randomized, double-blind, placebo-controlled trials. The Phase 3 program is recruiting a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. The Phase 3 studies are actively recruiting Alzheimer’s patients in over 100 clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia.

About Simufilam
Simufilam (sim-uh-FILL-am) is the chemical name for Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.

Pacira BioSciences Reports Full-Year and Fourth Quarter 2022 Financial Results

On February 28, 2023 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the fourth quarter and full-year of 2022 (Filing, 8-K, Pacira Pharmaceuticals, FEB 28, 2023, View Source [SID1234627870]).

"2022 was a solid year for Pacira as we posted record revenue and significant adjusted EBITDA, recently surpassed our twelve millionth patient with EXPAREL, and advanced our product portfolio into new and exciting indications," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "We enter 2023 in a strong position with significant and durable cash flows that we believe will allow us to leverage our balance sheet to self-fund our growth and expansion. In the coming year we expect to achieve a variety of value-driving milestones including growing product revenue, developing new indications for our commercial offering, advancing our clinical pipeline, improving gross margins, increasing cash flow, and pre-paying significant portions of our term loan B debt, which would further strengthen our balance sheet."

"The need for non-opioid pain management remains a global imperative and our continued progress further solidifies our leadership role in this important work," added Mr. Stack.
2022 Full-Year and Fourth Quarter Financial Highlights
•Full-year revenues of $666.8 million and fourth quarter revenues of $172.0 million.
•Full-year GAAP net income of $15.9 million or $0.35 per basic share and $0.34 per diluted share.
•Fourth quarter GAAP net loss of $10.1 million or $0.22 per basic and diluted share.
•Full-year adjusted EBITDA of $212.7 million and fourth quarter adjusted EBITDA of $58.8 million.
See "Non-GAAP Financial Information" below.
Recent Business Highlights
•Second Innovation and Training Center Opened in Houston. In January 2023, Pacira opened its second Innovation and Training Center in Houston. This state-of-the-art facility features a 125-seat adaptive lecture hall, broadcast studio and both wet and dry lab space for cadaver and other interactive workshops, as well as advanced ultrasound machines equipped with artificial intelligence training software. The Company believes this training center is core to developing

physician thought leaders and community-based clinicians wanting to stay at the forefront of opioid-sparing pain management.
•Supplemental New Drug Application Submitted for EXPAREL. In January 2023, Pacira submitted its supplemental New Drug Application, or sNDA, to the U.S. Food and Drug Administration seeking expansion of the EXPAREL label to include sciatic nerve blocks in the popliteal fossa and femoral nerve blocks in the adductor canal. The sNDA is supported by two successful Phase 3 studies in which EXPAREL achieved statistically significant reductions in postsurgical pain control and opioid consumption through 96 hours compared with bupivacaine HCl.
•New Data Support Cryoneurolysis, or Cold Therapy, as Potential Spasticity Treatment. In January 2023, investigators presented three datasets supporting cryoneurolysis, or cold therapy, as a potential future treatment strategy for managing spasticity. The data were presented at the Annual Meeting of Academic Physiatrists in Anaheim. Pacira is preparing to initiate a registration study evaluating its iovera° cryoneurolysis system as a treatment for spasticity. The iovera° system is commercially available as an innovative pain relief treatment. It uses extreme cold to stop nerves from sending pain signals to the brain, the effect is immediate, and can last 90 days.
•New ZILRETTA Data to be Presented at Osteoarthritic Research Society World Congress. In March 2023, investigators will present the results of a Phase 2 study comparing ZILRETTA to immediate-release triamcinolone in patients with osteoarthritis of the knee and Type 2 diabetes. The data will be presented at the Osteoarthritic Research Society World Congress in Denver.
Fourth Quarter 2022 Financial Results
•Total revenues were $172.0 million in the fourth quarter of 2022, an 8% increase over the $159.2 million reported for the fourth quarter of 2021.
•EXPAREL net product sales were $138.0 million in the fourth quarter of 2022, a 1% decrease versus the $139.9 million reported for the fourth quarter of 2021.
•ZILRETTA net product sales were $28.0 million in the fourth quarter of 2022, a 121% increase over the $12.7 million reported for the fourth quarter of 2021. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion in November 2021.
•Fourth quarter 2022 iovera° net product sales were $4.6 million, a 7% decrease versus the $4.9 million reported in the fourth quarter of 2021.
•Sales of bupivacaine liposome injectable suspension to third-party licensees were $1.0 million in the fourth quarter of 2022, versus the $1.1 million reported for the fourth quarter of 2021.
•Fourth quarter royalty and collaborative licensing and milestone revenues were $0.4 million in 2022 versus $0.6 million in 2021.
•Total operating expenses were $181.8 million in the fourth quarter of 2022, versus the $155.0 million reported for the fourth quarter of 2021. Included in operating expenses in 2022 was a $26.1 million impairment of acquired in-process research and development.
•Research and development (R&D) expenses were $17.5 million in the fourth quarter of 2022, compared to $15.5 million in the fourth quarter of 2021. The company’s R&D expenses included $7.3 million and $5.3 million of product development and manufacturing capacity expansion costs in the fourth quarters of 2022 and 2021, respectively.
•Selling, general and administrative (SG&A) expenses were $64.0 million in the fourth quarter of 2022, compared to $52.2 million in the fourth quarter of 2021.

•GAAP net loss was $10.1 million, or $0.22 per basic and diluted share in the fourth quarter of 2022, compared to a GAAP net loss of $5.1 million, or $0.12 per basic and diluted share in the fourth quarter of 2021.
•Non-GAAP net income was $37.0 million, or $0.81 per basic share and $0.80 per diluted share in the fourth quarter of 2022, compared to non-GAAP net income of $44.4 million, or $0.99 per basic share and $0.97 per diluted share in the fourth quarter of 2021.
•Adjusted EBITDA was $58.8 million in the fourth quarter of 2022, a 15% decrease compared to $69.3 million in the fourth quarter of 2021.
•Pacira ended the fourth quarter of 2022 with cash, cash equivalents and available-for-sale investments ("cash") of $325.9 million. Cash provided by operations was $42.0 million in the fourth quarter of 2022, compared to $23.2 million in the fourth quarter of 2021.
•Pacira had 45.9 million basic and diluted weighted average shares of common stock outstanding in the fourth quarter of 2022.
•For non-GAAP measures, Pacira had 46.3 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2022.
See "Non-GAAP Financial Information" below.
Full-Year 2022 Financial Results

•Total revenues were $666.8 million in 2022, a 23% increase over the $541.5 million reported in 2021.
•EXPAREL net product sales were $536.9 million in 2022, a 6% increase over the $506.5 million reported in 2021.
•ZILRETTA net product sales were $105.5 million in 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion in November 2021.
•Full-year iovera° net product sales were $15.3 million, a 6% decrease over the $16.2 million reported in 2021.
•Full-year sales of bupivacaine liposome injectable suspension to third-party licensees were $6.5 million in 2022, versus the $3.6 million reported in 2021.
•Full-year royalty and collaborative licensing and milestone revenues sales were $2.7 million in 2022, versus the $2.6 million reported in 2021.
•Total operating expenses were $606.8 million in 2022, compared to $451.6 million in 2021.
•R&D expenses were $84.8 million in 2022, compared to $55.5 million in 2021. The company’s R&D expenses include $24.6 million and $19.4 million of product development and manufacturing capacity expansion costs in 2022 and 2021, respectively.
•Selling, general and administrative (SG&A) expenses were $254.5 million in 2022, compared to $199.3 million in 2021.
•GAAP net income was $15.9 million, or $0.35 per basic share and $0.34 per diluted share in 2022, compared to GAAP net income of $42.0 million, or $0.95 per basic share and $0.92 per diluted share in 2021.

•Non-GAAP net income was $120.7 million, or $2.65 per basic share and $2.59 per diluted share in 2022, compared to non-GAAP net income of $136.7 million, or $3.09 per basic share and $3.00 per diluted share in 2021.
•Adjusted EBITDA was $212.7 million in 2022, a 4% increase over $204.0 million in 2021.
•Cash provided by operations was $145.3 million in 2022, compared to $125.7 million in 2021.
•Pacira had 45.5 million basic and 46.5 million diluted weighted average shares of common stock outstanding in 2022.
See "Non-GAAP Financial Information" below.
2023 Financial Guidance
Today the company is providing full-year 2023 financial guidance as follows:
•EXPAREL net product sales of $570 million to $580 million;
•ZILRETTA net product sales of $115 million to $125 million;
•iovera° net product sales of $17 million to $20 million;
•Non-GAAP Gross margin of 76% to 78%;
•Non-GAAP R&D expense of $70 million to $80 million;
•Non-GAAP SG&A expense of $220 million to $230 million; and
•Stock-based compensation of $51 million to $54 million.
See "Non-GAAP Financial Information" below.
Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Tuesday, February 28, 2023, at 8:30 a.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information
This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP gross margin, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, non-GAAP net income, non-GAAP net income per common share, non-GAAP weighted average diluted common shares outstanding, EBITDA (earnings before interest, taxes, depreciation and amortization) and adjusted EBITDA, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to estimate its future cost of goods sold, R&D expense and SG&A expense outlook and to better analyze its financial results and help make managerial decisions. In

management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the ongoing operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

NuCana to Participate in Two Upcoming Investor Conferences

On February 28, 2023 NuCana plc (Nasdaq: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will participate in two upcoming investor conferences (Press release, Nucana BioPharmaceuticals, FEB 28, 2023, View Source [SID1234627869]).

Event: Cowen’s 43rd Annual Healthcare Conference
Presentation Date: Tuesday, March 7, 2023
Presentation Time: 10:30 AM ET

Event: Oppenheimer’s 33rd Annual Healthcare Conference
Presentation Date: Tuesday, March 14, 2023
Presentation Time: 12:40 PM ET

The presentations at both conferences will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

Novavax Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights

On February 28, 2023 Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, reported its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2022 (Press release, Novavax, FEB 28, 2023, View Source [SID1234627868]).

"I am excited to be joining Novavax at this important time in the company’s history," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Much has been achieved over the past three years, and based on the foundation that has been laid to date, I believe that Novavax has significant potential for a bright future."

"Over the past few weeks, the management team and I have identified three near-term priorities that we believe are essential to our success this year and beyond: 1) to deliver a competitive product for the upcoming 2023 fall vaccination season; 2) to reduce our rate of spend, manage our cash flow, and evolve our scale and structure; and 3) to leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. We believe that if we succeed in executing against these priorities, we will position the company well for long-term success."

Fourth Quarter 2022 and Recent Highlights

COVID-19 Vaccine Orders and Plans for the 2023 Fall Vaccination Season

· Delivered over 100 million doses of Nuvaxovid, Novavax’s COVID-19 vaccine, globally to date

· Modified agreement with the U.S. government for up to 1.5 million additional doses of Novavax’s COVID-19 vaccine for delivery in 2023
o Agreement maintains the U.S. public’s access to Novavax’s COVID-19 vaccine and supports the development of smaller dose vials, strain selection in line with U.S. Food and Drug Administration (FDA) recommendations and a smooth transition to the commercial market

· Reaffirmed intent to deliver an updated mono- or bivalent strain vaccine for the 2023 fall vaccination season, consistent with public health recommendations

· Secured European Medicines Agency (EMA) and FDA approval of Nuvaxovid five-dose vial variation and EMA approval of the Company’s Czech Republic facility to manufacture antigen and supply Nuvaxovid to the E.U.

COVID-19 Vaccine Clinical Development Program and Expanded Authorizations

· Presented data to the U.S. FDA Vaccine and Related Biological Products Advisory Committee demonstrating that when used as a booster, Novavax’s COVID-19 vaccine induces broad functional immune responses, including for contemporary variants

· Announced topline results from Phase 3 COVID-19 Omicron BA.1 vaccine candidate, achieving the primary strain-change endpoint
o Part 2 to evaluate our prototype vaccine compared to an Omicron BA.5 vaccine, as well as a bivalent containing prototype and Omicron BA.5 vaccine

· Expanded Nuvaxovid label in adult booster and adolescent primary series to enable broader uptake in the long-term commercial market

COVID-19-Influenza Combination (CIC) Vaccine Candidate Clinical Development

· Initiated Phase 2 dose-confirming trial to evaluate safety and immunogenicity of different formulations of CIC and influenza stand-alone vaccine candidates in adults aged 50 to 80 years, with topline results expected by mid-year 2023

· CIC Phase 2 trial includes additional study arms exploring alternate influenza stand-alone formulations

Corporate Highlights

· Appointed John C. Jacobs, President and Chief Executive Officer and a member of the Board of Directors, following the retirement of Stanley C. Erck, who served as President and Chief Executive Officer for 12 years

· Appointed Elaine O’Hara, Chief Strategy Officer, joining the organization to focus on business and corporate development, portfolio strategy and alliance management

· Reorganized executive leadership team to better align internal resources and operate more efficiently; key changes include:
o Filip Dubovsky, Executive Vice President, assumes the role of President, Research & Development (R&D) following the retirement of Gregory M. Glenn, MD. Dr. Glenn will move into a consulting role as a strategic R&D advisor
o Silvia Taylor, Executive Vice President, promoted to Chief Corporate Affairs and Advocacy Officer with expanded responsibilities for government affairs, policy and advocacy, in addition to her communications role
o Troy Morgan, Chief Compliance Officer, remains in role and now reports directly to John C. Jacobs to elevate the company’s focus on compliance
o Jim Kelly, Chief Financial Officer, assumes responsibility for investor relations

· Strengthened Board of Directors with appointment of Rick Rodgers, adding extensive biopharmaceutical experience and financial leadership

· Raised $250 million in concurrent convertible senior notes and common stock offerings

Fourth Quarter and Full Year 2022 Financial Results

· Total revenue for the fourth quarter 2022 was $357 million and reflects 61% growth compared to $222 million in the same period in 2021. Total revenue for the full year 2022 was $1.9 billion and reflects 73% growth compared to $1.1 billion in the same period in 2021. The growth in each period is the result of Nuvaxovid product sales that offset a decline in Grants, Royalties and Other Revenue and reflects the transition of Novavax to a commercial stage company.

· Cost of sales for the fourth quarter and full year 2022 were $182 million and $903 million, respectively. These periods included $99 million and $604 million, respectively, related to excess, obsolete, or expired inventory and losses on firm purchase commitments under our third-party supply agreements.

· Research and development expenses for the fourth quarter of 2022 were $258 million as compared to $963 million in the same period in 2021. Research and development expenses for the full year 2022 were $1.2 billion compared to $2.5 billion in the same period in 2021. The decrease in both periods was primarily due to a decrease in development activities relating to coronavirus vaccines and an increased amount of manufacturing network costs capitalized to inventory that previously were expensed to research and development.

· Selling, general and administrative expenses for the fourth quarter of 2022 were $162 million compared to $84 million for the same period in 2021. Selling, general and administrative expenses for the full year 2022 were $489 million compared to $298 million for the same period in 2021. Expenses in both periods increased due to the commencement of commercial sales operations in support of Novavax’s COVID-19 vaccine program.

· Net loss for the fourth quarter 2022 was $182 million as compared to a net loss of $846 million in the same period in 2021. Net loss for the full year 2022 was $658 million compared to a net loss of $1.7 billion in the same period in 2021.

· Cash, cash equivalents, and restricted cash were $1.3 billion as of December 31, 2022, compared to $1.5 billion as of December 31, 2021. In December 2022, Novavax raised $250 million gross proceeds in concurrent equity and convertible securities offerings. In January 2023, Novavax funded the maturity of its $325 million convertible notes.

Financial Framework

In 2023, Novavax intends to focus the organization to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health recommendations for strain composition for the 2023 fall vaccination season. To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position the company to deliver long-term growth.

While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration. Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued.

The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. A more detailed discussion of Novavax’s liquidity position and risk related thereto will be set forth in Novavax’s Annual Report on Form 10-K that will be filed with the SEC.

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 February 28, 2023 until 11:59 p.m. ET on March 7, 2023. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418.

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 May 28, 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 Nuvaxovid (NVX-CoV2373

Novavax’s COVID-19 vaccine is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax’s unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.

About Matrix-M Adjuvant

When added to vaccines, Novavax’s patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About the COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial

The COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80. The trial will assess a CIC vaccine comprised of Novavax’s recombinant protein-based COVID-19 vaccine, quadrivalent influenza vaccine candidate, and patented saponin-based Matrix-M adjuvant. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. The Phase 2 dose-confirmation trial will be conducted in two parts. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. Initial results are expected mid-year 2023. These data will inform the phase 3 trials for both influenza stand-alone and COVID-19-influenza combination vaccine candidates.