Schrödinger Reports Financial Results for the Fourth Quarter and Full Year 2020 and Provides Outlook for 2021

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.

Aldeyra Therapeutics Schedules Webcast and Conference Call to Report Full-Year 2020 Financial Results and Discuss Recent Business Highlights

On March 4, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported that it will host a conference call at 8:00 a.m. ET Thursday, March 11, 2021 to report financial results for the year ended December 31, 2020 and discuss recent business highlights (Press release, Aldeyra Therapeutics, MAR 4, 2021, View Source [SID1234576116]).

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The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. A live webcast of the conference call will also be available on the Investors & Media page of the company’s corporate website at View Source

After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

DNAtrix Announces First Patient Dosed in Clinical Study of DNX-2440, an OX40 Ligand Expressing Immunotherapy, in Colorectal Cancer and Other Cancers with Liver Metastasis

On March 4, 2021 DNAtrix, a biotech company advancing virus-driven immunotherapies for cancer, reported the treatment of the first patient in a Phase 1 dose-escalation and dose-expansion study of DNX-2440, an OX40 ligand encoding oncolytic adenovirus, in patients with resectable liver metastasis (Press release, DNAtrix, MAR 4, 2021, View Source [SID1234576132]). Expression of OX40 ligand on the surface of tumor cells is expected to enhance anti-tumor immune responses by providing costimulatory signals to T cells within the tumor microenvironment.

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"We are excited to clinically explore the potential of one of our immunotherapy drug candidates, which is based on our proprietary adenovirus platform technology, in additional cancer indications," said Jeffrey Knapp, chief executive officer of DNAtrix. "Our preclinical work with DNX-2440 has demonstrated that infection of human tumor cell lines with this agent leads to viral replication, high level expression of OX40 ligand on tumor cells and effective tumor cell killing. Mouse tumor models showed specific anti-tumor immune memory, abscopal effect, and improved survival. This two-part clinical study is designed to directly demonstrate the activity of DNX-2440 and potential as therapy for colorectal cancer, as well as data with other tumor types where liver metastases occur."

The Phase 1 clinical trial of DNX-2440 will be conducted in 24-30 patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have liver resection with curative-intent. Patients will receive two sequential (2 weeks apart) intra-tumoral injections of DNX-2440 into a liver metastasis prior to surgery for liver resection to evaluate safety and biological endpoints. The first part of the Phase 1 study is a dose-escalation phase evaluating three different dose levels of DNX-2440 in 12-18 patients with liver metastasis from tumors of various origins. Following the completion of dose-escalation, the selected dose will be further evaluated in an expansion phase where DNX-2440 will be administered using the same schedule to 12 patients with colorectal cancer liver metastasis. The primary endpoint of the study is to establish safety and identify a maximum tolerated dose. Secondary endpoints include evaluating tumor cell killing of injected and uninjected tumors, determining viral replication in the injected tumor and measuring local and systemic anti-tumor immune responses.

Daniel A. Anaya, M.D., FACS, head of the Hepatobiliary Group and chief of the Division of GI Surgery in the Department of Gastrointestinal Oncology at the Moffitt Cancer Center, and principal investigator of the study, added, "DNX-2440 is an innovative therapy that has shown promising preclinical results, including durable tumor responses. As a leading cancer center, we are committed to providing cutting-edge treatment approaches in our fight against cancer and are pleased to launch this collaborative clinical study."

About DNX-2440
DNX-2440 is an oncolytic adenovirus expressing the immune modulator OX40 ligand, a powerful costimulatory molecule known to enhance T cell responses directed to tumors. DNX-2440 is in Phase 1 clinical testing following the demonstration of anti-cancer activity in preclinical studies, including tumor reductions, immune memory, and abscopal effect.

KemPharm to Present at the 33rd Annual Roth Conference

On March 4, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that Travis C. Mickle, Ph.D., President and CEO of KemPharm, will present at the 33rd Annual Roth Conference being held virtually from March 15-17, 2021 (Press release, KemPharm, MAR 4, 2021, View Source [SID1234576154]). The presentation will be available on demand during the virtual event for all registered attendees.

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Details regarding KemPharm’s presentations are as follows:

Event:   33rd Annual Roth Conference
Date:    Monday, March 15, 2021 to Wednesday, March 17, 2021
Time: Available on Demand
Registration:   View Source
During the pre-recorded virtual presentation, Dr. Mickle will provide an overview of KemPharm’s corporate achievements and potential milestones, including the U.S. Food and Drug Administration’s (FDA) recent approval of AZSTARYS (formerly known as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

The complete label for AZSTARYS, including prescribing information and important safety information, may be found at View Source

Replimune to Present at Three Upcoming Investor Conferences

On March 4, 2021 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that members from the Replimune management team will present and host one-on-one meetings at the following three virtual investor conferences (Press release, Replimune, MAR 4, 2021, View Source [SID1234576069]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Pre-Recorded Formal Presentation will be made live: Tuesday, March 9, 2021 at 7:00 am ET

Barclays Global Healthcare Conference
Date: Thursday, March 11, 2021
Fireside Chat Presentation Time: 9:10 am ET

33rd Annual Roth Conference
Date: Wednesday, March 17, 2021
Presentation Time: 1:30 pm ET

A simultaneous webcast of the fireside chat presentation at the Barclays Global Healthcare Conference will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for approximately 90 days following the conference.