On March 4, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the fourth quarter and full year ended December 31, 2020, and provided its financial outlook for 2021 (Press release, Schrodinger, MAR 4, 2021, View Source [SID1234576100]).

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"2020 was a very strong year for Schrödinger across all aspects of our business. Software revenue increased substantially, and we expect continued growth in 2021. We believe this growth reflects the power of our physics-based platform to accelerate the discovery of new medicines and materials," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger.

"We finished 2020 in a strong financial position. Looking across multiple key indicators, we believe our underlying business is poised for continued growth this year," said Joel Lebowitz, chief financial officer at Schrödinger. "Importantly, our balance sheet and growing revenue enable us to make strategic investments in both our computational platform and our internal pipeline to build for the future."

Business Highlights

Delivered strong operating performance and strategic execution

Reported 28 percent total revenue growth in the fourth quarter of 2020, driven by continued uptake of Schrödinger’s core technologies including FEP+ and its enterprise solution, LiveDesign
Entered into a strategic collaboration with Bristol Myers Squibb to discover, develop, and commercialize therapeutics in multiple disease areas. Under the terms of the agreement, Schrödinger received $55 million in an upfront payment and is eligible to receive up to $2.7 billion in preclinical, development, regulatory and sales-based milestone payments in addition to royalties on net sales of each product commercialized by Bristol Myers Squibb.
Ended the fourth quarter of 2020 with cash, cash equivalents, restricted cash and marketable securities of $643.2 million, compared to $599.5 million at September 30, 2020
Progressed internal pipeline

Presented preclinical data on the company’s MALT1 inhibitor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlighting that its MALT1 inhibitors demonstrated anti-tumor activity alone and in combination with approved anti-cancer therapies in models of B-cell lymphoma
Continued to advance multiple programs toward IND-enabling studies; subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission expected in the first half of next year
Advanced discovery efforts to allow addition of new programs to the company’s internal pipeline in 2021
Advanced the science underlying Schrödinger’s computational platform

Expanded its collaboration with Google Cloud to further increase the speed and capacity of its computational platform, effectively tripling Schrödinger’s previous throughput under the collaboration
Released a major update to Schrödinger’s proprietary force field, called OPLS4, which underlies Schrödinger’s most powerful molecular design technologies, such as FEP+, allowing for even greater accuracy of the computational predictions
Published four scientific papers, including a publication describing how to improve outcomes for fragment linking, an important technique used in early drug discovery, to potentially enable the design of novel drug-like inhibitors for challenging targets
Fourth Quarter 2020 Financial Results

Revenue was $33.0 million for the fourth quarter of 2020, an increase of 28 percent compared to the fourth quarter of 2019.
Software revenue was $25.0 million for the fourth quarter of 2020, an increase of 42 percent compared to the fourth quarter in 2019.
Drug discovery revenue was $8.1 million for the fourth quarter of 2020, compared to $8.3 million in the fourth quarter of 2019. Drug discovery revenue in the fourth quarter of 2020 included $1.0 million related to the $55 million up-front payment from the strategic agreement with Bristol Myers Squibb announced in November 2020.
Gross profit was $19.0 million in the fourth quarter of 2020, an increase of 22 percent over the fourth quarter in 2019. Software gross margin was 77 percent in the fourth quarter, compared to 79 percent for the same period in the prior year.
Operating expenses for the fourth quarter of 2020 were $35.6 million, compared to $23.4 million in fourth quarter of 2019.
Other income, which included gains on equity investments, changes in fair value of such investments and interest income, was $5.2 million in the fourth quarter of 2020 compared to $0.7 million for the fourth quarter of 2019. Other income for the fourth quarter of 2020 included a $5.2 million non-cash gain from Schrödinger’s equity stake in Morphic Therapeutic.
Net loss, after adjusting for non-controlling interests, was $11.1 million for the fourth quarter of 2020, compared to a net loss of $6.8 million in the fourth quarter of 2019.
Full Year 2020 Financial Results

Total revenue was $108.1 million for 2020, an increase of 26 percent compared to 2019.
Software revenue was $92.5 million for 2020, an increase of 39 percent over 2019.
Drug discovery revenue was $15.6 million for 2020, compared to $18.8 million in 2019.
Gross profit was $63.5 million for 2020, an increase of 29 percent over 2019. Software gross margin was 81 percent for the year, compared to 80 percent in 2019.
Operating expenses for 2020 were $124.4 million, compared to $87.8 million in 2019.
Other income, which included gains on equity investments, changes in fair value of such investments and interest income was $34.6 million in 2020 compared to $12.7 million in 2019. Other income for 2020 included a $17.6 million non-cash gain from Schrödinger’s equity stake in Relay Therapeutics and a $13.7 million non-cash gain from the company’s equity stake in Morphic Therapeutic, partially offset by a loss of $3.0 million related to the company’s equity stake in Nimbus Therapeutics.
Net loss, after adjusting for non-controlling interests, was $24.5 million for 2020, compared to a net loss of $24.6 million in 2019.
At December 31, 2020, Schrödinger had cash, cash equivalents, restricted cash and marketable securities of $643.2 million.
Full Year 2020 Key Performance Indicators

Total annual contract value (ACV) was $92.1 million in 2020, up 22 percent over 2019
Number of customers over $1 million in ACV was 16 in 2020, up from 10 in 2019
Number of customers over $100,000 in ACV was 153 in 2020, up from 131 in 2019; customer retention in this cohort was 99 percent
Number of Active Customers with ACV over $1,000 was 1,463, up from 1,266 in 2019
For additional information about our Key Performance Indicators, see "Operating Metrics" below.

Full-Year 2021 Revenue Outlook
As of March 4, 2021, Schrödinger expects total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million, and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ended December 31, 2021.

Webcast and Conference Call Information
Schrödinger will host a conference call to discuss its third quarter financial results on Thursday, March 4, 2020, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 9686253. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website following the event.

On March 4, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the H.C. Wainwright Global Life Sciences Conference being held from March 9-10, 2021 (Press release, Anavex Life Sciences, MAR 4, 2021, View Source [SID1234576099]).

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A webcast of the on-demand presentation will be available beginning Tuesday, March 9, 2021 on the Company’s website at www.anavex.com.

On March 4, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, will be presenting at the H.C. Wainwright Life Sciences Conference to be held virtually between March 9-10, 2021 (Press release, AIM ImmunoTech, MAR 4, 2021, View Source [SID1234576098]).

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AIM’s presentation will be available on-demand to registered attendees via the conference platform beginning Tuesday, March 9, 2021, at 7:00 AM Eastern Time. The webcast will be accessible here, and the presentation will be available on the investor relations section of AIM’s website at View Source Management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

On March 4, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported that it will release its fourth quarter and full-year 2020 financial results on Wednesday, March 10, 2021 after the markets close (Press release, Lexicon Pharmaceuticals, MAR 4, 2021, View Source [SID1234576096]). Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update.

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The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

On March 4, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Repare Therapeutics, MAR 4, 2021, View Source [SID1234576095]).

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"We met or exceeded key business and program milestones in 2020. In the first half, we secured more than $300 million in new balance sheet capital from our IPO and from the up-front payments associated with our Bristol Myers Squibb collaboration, all of which we believe will accelerate program progress. In the second half, we continued to execute on our strategic goals by successfully launching our Phase 1/2 clinical trial for RP-3500, which is currently enrolling patients. 10 sites have been activated across North America and Europe," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We continue to advance our discovery platform and have now designated our second clinical program, RP-6306, for which we have initiated IND-enabling studies."

Mr. Segal added: "2021 will be a pivotal year for Repare. We have already expanded the scope of our RP-3500 trial with the initiation of patient recruitment of the PARP-inhibitor combination portion of our study, and by virtue of our execution to-date, we have re-affirmed our expectation to release initial results for the monotherapy portion of the trial in the second half of the year. In addition, we now expect to bring our CCNE1 synthetic lethal target development program, RP-6306, into the clinic in the second quarter of this year, a quarter ahead of previously announced guidance, and look forward to discussing it in more detail during our RP-6306-focused Virtual Investor Day on Thursday, April 8th. Finally, we continue to leverage our proprietary, genome-wide, CRISPR-enabled SNIPRx platform and are now actively pursuing eight discovery-stage inhibitor programs in addition to other candidates that are part of our ongoing collaboration with Bristol Myers Squibb."

2020 Highlights and 2021 Outlook:

Initiated a Phase 1/2 clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer’s PARPi, talazoparib, in patients with solid tumors.
In July 2020, the Company began dosing in a Phase 1/2 clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors in patients with specific genome instability-related genetic alterations, including those in the ATM gene (ataxia telangiectasia mutated kinase).
Repare has now activated 10 clinical trial sites across North America and Europe, and is now actively screening patients to evaluate RP-3500 in a combination arm with Pfizer’s PARP inhibitor, talazoparib, in addition to monotherapy.
Initial results are expected to be reported in the monotherapy arm of the trial in the second half of 2021.
Advanced RP-6306, our CCNE-1 synthetic lethal inhibitor program, into IND enabling studies.
The Company anticipates initiating a Phase 1 clinical trial for RP-6306 in the second quarter of 2021, ahead of its previously announced guidance, and plans to host a Virtual Investor Day on Thursday, April 8, 2021 to further discuss this program.
Advanced the development of our earlier stage discovery programs
Repare is actively pursuing eight discovery pipeline initiatives in addition to its ongoing collaboration with Bristol Myers Squibb. Several of these synthetic lethal discovery targets have progressed into active chemistry programs.
The Company is now expected to initiate IND enabling studies in H1 2022 for its third synthetic lethal asset, its Polθ inhibitor program, versus previously announced guidance of H2 2021.
Corporate Updates
In December 2020, the Company was added to the NASDAQ Biotechnology Index (NASDAQ: ^NBI). Repare’s addition to the NBI became effective on Monday, December 21, 2020.
Fourth Quarter and Full Year 2020 Financial Results:

Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of December 31, 2020 were $333.9 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $40.1 million and $21.0 million for the years ended December 31, 2020 and 2019, respectively. The increase in R&D expenses year over year was primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses and certain other R&D expenses.
General and administrative (G&A) expenses: G&A expenses were $14.3 million and $5.4 million for the years ended December 31, 2020 and 2019, respectively. The increase in G&A expenses year over year was due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs, all of which increased as a result of the Company’s recent IPO and transition to a public company.
Net loss: Net loss was $53.4 million, or $2.66 per share in the year ended December 31, 2020 and $27.2 million, or $17.81 per share, in the year ended December 31, 2019.
Conference Call Details for RP-6306-focused Virtual Investor Day on Thursday, April 8, 2021

Repare Therapeutics will host a RP-6306-focused Virtual Investor Day on Thursday, April 8, 2021 at 10:30 a.m. ET to discuss RP-6306, a CCNE-1 synthetic lethal inhibitor undergoing IND-enabling studies. The Company anticipates commencing a Phase 1 clinical trial in the second quarter of 2021, a quarter earlier than previously announced guidance. Repare Therapeutics’ executive management team will be joined by two distinguished physicians:

Carol Aghajaian, MD – Chief, Gynecologic Medical Oncology Service, Professor of Medicine, Weill Cornell Medical College, Memorial Sloan Kettering Cancer Center; and
Timothy Yap, MBBS, PhD, FRCP, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, MD Anderson Center
To access the conference call, please dial (833) 638-9655 or (602) 585-9856 (international) at least 10 minutes prior to the start time and refer to conference ID 1093819. Presentation slides will be available to download from the Company’s website.

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those patients most likely to achieve clinical benefit from resulting product candidates.