Earnings Labs

Novavax, Inc. (NVAX)

Q3 2020 Earnings Call· Mon, Nov 9, 2020

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Third Quarter 2020 Financial Operating Results and Operating Highlights. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Senior Vice President Investor Relations and Corporate Affairs, Silvia Taylor. Thank you. Please go ahead ma'am.

Silvia Taylor

Analyst

Good afternoon and thank you to everyone who has joined today's call to discuss our third quarter 2020 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later today. Joining me today are Stan Erck, President and CEO; and John Trizzino, current Executive Vice-President, Chief Financial Officer and Chief Business Officer, and newly appointed to become Chief Commercial Officer and Chief Business Officer. Dr. Greg Glenn, President of R&D; and Dr. Filip Dubovsky, our recently promoted Executive Vice President and Chief Medical Officer will be available for the Q&A section of today's call. Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements relating to future financial or business performance, condition or strategy and other financial and business related matters, including expectations regarding revenue, operating expenses, cash usage in clinical development and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. I would now like to hand the call over to Stan. Stan?

Stan Erck

Analyst

Thanks, Sylvia. Actually before I begin what I'd like to do is congratulations to our colleagues at Pfizer. They had a great result. They did a great job. It's a remarkable effort on their part. And it's great for global health. It's great for the vaccine industry. And truly it's great for all the efforts of our colleagues developing a spike protein to stop the coronavirus pandemic. It shows that the vaccine will work, and congratulations to Pfizer. So with that in our third quarter and continuing through today, reflects the accelerated expansion of Novavax in every functional area. With the ongoing Phase 3 clinical trial in the U.K. we are now just months away from Phase 3 efficacy data for a COVID-19 vaccine. On last quarter's call, we detailed our clinical program and highlighted the substantial manufacturing and development agreements we completed. We have made further progress in all these efforts for our COVID-19 vaccine and we will be discussing those today. I'll start with an update on all of our COVID-19 vaccine activity in the quarter and recent weeks, and then following that I'll quickly provide an update on NanoFlu. John will then review the financials for the quarter. We will then take your questions. As I'm sure you all know by now after initiating early-stage development efforts in January of this year, we identified Novavax CoV2373 as our lead vaccine candidate in April. And for simplicity I will refer to our candidate as 2373 today. Following preclinical testing that demonstrated high immunogenicity, we quickly began clinical testing in a U.S.-Australia Phase 1/2 trial. In mid-August we initiated a Phase 2b trial in South Africa followed a week later by the initiation of the Phase 2 portion of the Phase 1/2 clinical trial in the U.S. and Australia.…

John Trizzino

Analyst

Thank you, Stan. Today we announced the financial results for the third quarter and first nine months of 2020. Given our focus on 2373 development and a significant amount of grant funding to support its development, it makes comparison to last year to not be materially relevant. So therefore, I'll focus most of my comments on the third quarter 2020 results only. For the third quarter we reported a net loss of $197.3 million or $3.21 per share. Revenue in the quarter was $157 million and was primarily the result of services performed under our participation in Operation Warp Speed, the CEPI agreement and a Department of Defense contract. We recognize revenue as we complete services under our funding agreements and also report expenses as incurred. R&D expenses were $294.1 million in the third quarter of 2020. These expenses were primarily related to development activities of 2373 and included, approximately $122 million of non-cash expense in the period that related to embedded leases under U.S. accounting principles. It is important to highlight this accounting treatment given its impact to total operating expenses for the quarter. Excluding this charge from total operating expenses brings our R&D expenses in line with revenue. G&A expenses were $56.9 million in the third quarter of 2020. Expenses from the quarter were primarily from increased employee stock-based compensation expense and increased professional fees related to the integration of Novavax CZ and supporting our 2373 program. As of September 30 2020, Novavax had $571.6 million in cash, cash equivalents, marketable securities and restricted cash. Net cash provided by operations for the first nine months of 2020 was $86 million, compared to net cash used in operation activities of $112.9 million, for the same period in 2019. During this quarter, we raised $53.3 million in net proceeds through our ATM offerings, for a total of approximately $445.6 million since the beginning of the year. In addition in the second quarter of 2020, we entered into an agreement to sell Series A convertible preferred stock, convertible into 4.4 million shares of common stock, to an investment fund affiliated with RA Capital in a private placement. We received gross proceeds of $200 million. That concludes my financial review. And I'll now turn it back to Stan.

Stan Erck

Analyst

Thanks John. 2020, continues to be a productive year for Novavax. In the third quarter we took big steps toward achieving our goals in both, our COVID-19 vaccine program and NanoFlu. We expect Quarter four to be no different. As we head into 2021, we will continue to rise to the challenge presented to us and look to strengthen our record of executing and delivering. We look forward to keeping you updated on milestones and developments across all of our programs. As always, I would like to express my gratitude to the entire Novavax team as well as our collaboration partners, who make all of this possible. Your tireless efforts in this critical period have been invaluable. All of us here at Novavax are honored to be part of the solution to one of the most significant public health events of our lives. And with that, I'll turn it back over to the Operator, for Q&A. Operator?

Operator

Operator

Stan Erck

Analyst

All right. Well, thank you. It appears, we don't have questions or the question system isn't working right now. But if we have no questions, I'm happy to be able to present our Quarter two. We had a great quarter. And we'll continue to keep you updated. Thank you very much.

Operator

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.