Schrödinger Reports First Quarter 2022 Financial Results

On May 4, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the first quarter of 2022 (Press release, Schrodinger, MAY 4, 2022, View Source [SID1234613518]).

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"We began 2022 with a strong quarter, which included software revenue of $33.1 million, a 26 percent increase over the first quarter of 2021, driven primarily by continued adoption and scale up by existing customers," said Ramy Farid, Ph.D., chief executive officer of Schrödinger. "We are also seeing continued progress across our collaborative and internal drug discovery pipeline, further demonstrating the impact of our platform. Last month, we presented preclinical data from our Wee1 program, which highlighted our opportunity to advance a potential best-in-class Wee1 inhibitor into the clinic. We are working rapidly to progress our three most advanced internal programs into clinical development and are on track to submit an investigational new drug application for our MALT1 inhibitor, SGR-1505, to the FDA in the first half of 2022."

Strategic Objectives and Recent Business Highlights

In February 2022, Schrödinger laid out several strategic objectives for 2022-2023. Recent highlights include the following:

Internal Pipeline

Schrödinger is on track to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SGR-1505, its MALT1 inhibitor, in the first half of 2022. The company continues to plan to initiate a Phase 1 clinical study of SGR-1505 in patients with relapsed and resistant lymphoma in the second half of 2022. MALT1 is considered a potential therapeutic target for several non-Hodgkin’s B-cell lymphomas.

In April, Schrödinger presented new preclinical data from its Wee1 inhibitor program at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data underscore the therapeutic potential of Schrödinger’s Wee1 inhibitors for use as monotherapy and as part of combination therapy with other agents. Wee1 is emerging as a potentially important therapeutic target for a range of solid tumors, including ovarian and uterine cancer. Schrödinger continues to expect to select a Wee1 development candidate this year.

The company continues to advance its CDC7 development candidate through IND-enabling studies and expects to submit an IND to the FDA in early 2023. Targeting proteins such as CDC7 that play important roles in DNA replication and replication stress is gaining momentum as a new therapeutic approach based on the proliferative capacity of cancer cells to bypass DNA damage responses.

Schrödinger also continues to advance multiple undisclosed research programs in the areas of oncology and immunology.

Collaborative Programs

In March 2022, Morphic Therapeutic announced the initiation of a Phase 2a clinical study of MORF-057 in patients with moderate to severe ulcerative colitis. MORF-057 is a potent and selective, oral small molecule inhibitor of the α4β7 integrin being studied in patients with gastrointestinal disorders, initially targeting inflammatory bowel disease.

Materials Science

Today, Schrödinger announced that it recently entered into a three-year collaboration with Eonix LLC to accelerate the discovery and design of materials for safer, energy dense lithium ion batteries. As part of the agreement, Schrödinger received an equity stake in Eonix.

Underlying Science

During the first quarter, Schrödinger scientists continued to make scientific advances and were authors on 11 publications in peer-reviewed life sciences and materials science journals. Recent publications include reporting a novel extension to our neural network interaction potentials to more accurately model charge-charge interactions. Schrödinger anticipates that these improvements may enable more predictive modeling of polarization effects, reactivity, and polymorph stability, among a number of other endpoints of high importance to drug discovery and materials design.

2022 Financial Outlook

As of May 4, 2022, Schrödinger maintained the following expectations for the fiscal year ending December 31, 2022:

Total revenue expected to range from $161 million to $181 million, representing 17 percent to 31 percent growth over 2021

Total software revenue expected to range from $126 million to $136 million, representing 11 percent to 20 percent growth over 2021

Total drug discovery revenue expected to range from $35 million to $45 million, representing 42 to 82 percent growth over 2021

Operating expense growth is expected to be slightly lower than the 42 percent reported for the year ended December 31, 2021

Software gross margin percentage is expected to be in the mid-70s

For the second quarter of 2022, software revenue is expected to range from $28 to $30 million.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its first quarter 2022 financial results on Wednesday, May 4, 2022, at 4:30 p.m. ET. To participate in the live call, please dial (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and refer to conference ID 7896009. 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 for approximately 90 days following the event.

CRISPR Therapeutics to Present at the 2022 Bank of America Healthcare Conference

On May 4, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the 2022 Bank of America Healthcare Conference on Wednesday, May 11, 2022, at 4:40 p.m. PT (Press release, CRISPR Therapeutics, MAY 4, 2022, View Source [SID1234613535]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

PACIRA BIOSCIENCES REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS

On May 4, 2022 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 first quarter of 2022 (Press release, Pacira Pharmaceuticals, MAY 4, 2022, View Source [SID1234613553]).

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First Quarter 2022 Financial Highlights

Total revenues of $158.0 million
Net product sales of $129.2 million for EXPAREL, $23.6 million for ZILRETTA, and $3.0 million for iovera°
Net income of $6.8 million, or $0.15 per share (basic and diluted)
Adjusted EBITDA of $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted)
"We were delighted to end the first quarter of 2022 with record high EXPAREL sales for the month of March, which underscores the significant progress we continue to make despite operational headwinds in the elective surgery market due to COVID and labor-related disruptions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The successful integration of the Flexion acquisition was evidenced by strong ZILRETTA sales in the first quarter, which we expect to be an important near- and long-term contributor to earnings."

"We look forward to completing our two Phase 3 studies of EXPAREL for lower extremity nerve block and to launching new high-potential registration programs evaluating EXPAREL as a stellate ganglion block for cardiac dysrhythmia. Additionally, as the market moves rapidly toward ultrasound-guided iovera° blocks delivered by pain management specialists, we plan to use our IGOR registry to publish real-world evidence to better support our commercial initiatives," continued Mr. Stack.

Recent Business Highlights

Daryl Gaugler Appointed Chief Operating Officer. Today the company is announcing the appointment of Daryl Gaugler to the position of Chief Operating Officer effective May 4, 2022. Mr. Gaugler has served as the company’s Senior Vice President of Commercial Operations since June 2019. Mr. Gaugler is a seasoned life sciences executive with 30 years of experience in commercial leadership that includes building and directing over 400 commercial teams and designing go-to-market strategies for more than 20 companies. Prior to Pacira, Mr. Gaugler spent over 20 years with the Quintiles Transnational organization (now IQVIA). In his most recent role at Quintiles, President of North America Commercial Solutions, Mr. Gaugler delivered significant revenue and profit growth while leading customer satisfaction and employee engagement within the organization.

New EXPAREL Patents. In March and April 2022, the U.S. Patent and Trademark Office (U.S. PTO) issued Patent Numbers 11,278,494, 11,304,904 and 11,311,486. The ‘494 and ‘486 patents cover composition of EXPAREL while the ‘904 is a product by process patent, each having an expiration date of January 22, 2041. All three patents are now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange-Book).

Second Innovation and Training Facility. The company recently launched development plans for its second training facility in Houston, Texas. This 19,000 square-feet state-of-the-art facility will feature an adaptive lecture hall, broadcast studio, and lab space for cadaver and other interactive workshops. Together with the company’s Tampa facility, this second training center will play a core role in developing physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management. The company expects to open the Houston facility before the end of 2022 to host programs for EXPAREL, ZILRETTA and iovera°.
First Quarter 2022 Financial Results

Total revenues were $158.0 million in the first quarter of 2022, versus the $119.0 million reported for the first quarter of 2021.
EXPAREL net product sales were $129.2 million in the first quarter of 2022, versus the $114.7 million reported for the first quarter of 2021.
ZILRETTA net product sales were $23.6 million in the first quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
First quarter 2022 iovera° net product sales were $3.0 million, versus the $3.3 million reported for the first quarter of 2021.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.6 million in the first quarter of 2022, versus the $0.8 million reported for the first quarter of 2021.
First quarter 2022 royalty and collaborative licensing and milestone revenues were $0.6 million, versus the $0.3 million reported for the first quarter of 2021.
Total operating expenses were $140.6 million in the first quarter of 2022, versus the $99.6 million reported for the first quarter of 2021.
Research and development (R&D) expenses were $21.6 million in the first quarter of 2022, compared to $15.9 million in the first quarter of 2021. R&D expenses included $5.0 million and $4.7 million of product development and manufacturing capacity expansion costs in the first quarters of 2022 and 2021, respectively.
Selling, general and administrative (SG&A) expenses were $64.3 million in the first quarter of 2022, compared to $48.5 million in the first quarter of 2021.
GAAP net income was $6.8 million, or $0.15 per share (basic and diluted), in the first quarter of 2022, compared to $10.4 million, or $0.24 per share (basic) and $0.23 per share (diluted), in the first quarter of 2021.
Non-GAAP net income was $29.9 million, or $0.67 per share (basic) and $0.64 per share (diluted), in the first quarter of 2022, compared to $24.5 million, or $0.56 per share (basic) and $0.53 per share (diluted), in the first quarter of 2021.
Adjusted EBITDA was $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted) in the first quarter of 2022, compared to $36.2 million, or $0.83 per share (basic) and $0.79 per share (diluted) in the first quarter of 2021.
Pacira ended the first quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $452.2 million. Cash provided by operations was $30.8 million in the first quarter of 2022, compared to $12.1 million in the first quarter of 2021.
Pacira had 44.9 million basic and 46.4 million diluted weighted average shares of common stock outstanding in the first quarter of 2022.
See "Non-GAAP Financial Information" below.

Financial Guidance

The company’s product sales continue to be impacted by COVID-19, which has caused significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter.

Today the company is reiterating its full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million;
Non-GAAP SG&A expense of $220 million to $230 million; and
Stock-based compensation of $40 million to $45 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, Wednesday, May 4, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4063578. International callers may dial 1-720-545-0035 and use the same passcode. 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 will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4063578. The replay of the call will be available for one week from the date of the live call. 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 net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, adjusted EBITDA (as defined below) and adjusted EBITDA per share, 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 better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to 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 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.

Personalis Reports First Quarter 2022 Financial Results

On May 4, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter ended March 31, 2022 (Press release, Personalis, MAY 4, 2022, View Source [SID1234613571]).

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First Quarter and Recent Highlights

Reported quarterly revenue of $15.2 million in the first quarter of 2022 compared with $20.9 million in the first quarter of 2021
Revenue from biopharma and other customers, excluding the VA MVP (as defined below), of $11.7 million in the first quarter of 2022 compared with $7.7 million in the first quarter of 2021, a 53% increase; revenue from biopharma and other customers includes revenue of $4.1 million from Natera in the first quarter of 2022; revenue from biopharma customers excluding Natera of $7.6 million for the first quarter of 2022
Revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $3.5 million in the first quarter of 2022 compared with $13.2 million in the first quarter of 2021
Engaged with a large global pharmaceutical customer for NeXT Personal, and processed samples for initial order
Announced hiring of seasoned commercial executive James Azzaro to be Vice President, Diagnostics Sales
Received a new US patent for NeXT Personal, signifying its unique place among MRD assays as it combines a highly sensitive measurement of tumor burden with simultaneous tracking of thousands of tumor variants, both tumor-informed and prespecified, in a single panel
Cash, cash equivalents, and short-term investments were $266.5 million as of March 31, 2022
"We continue to be confident about our oncology revenue growth in the future due to the differentiation and strength of our offerings for both biopharma and diagnostic customers," said John West, Chief Executive Officer of Personalis. "We are making significant progress on our strategic priorities as we continue to build our clinical diagnostic team and work with world-class medical institutions. In particular, over the last several months we have announced collaborations with the Mayo Clinic and UCSD Moores Cancer Center. Our goal is to revolutionize the detection and treatment of cancer and contribute to more successful outcomes for all patients."

First Quarter 2022 Financial Results

Revenue was $15.2 million in the three months ended March 31, 2022
Gross margin was 28.1% in the three months ended March 31, 2022
Operating expenses were $32.6 million in the three months ended March 31, 2022
Net loss was $28.2 million in the three months ended March 31, 2022 and net loss per share was $0.63 based on a weighted-average basic and diluted share count of 45.0 million
Cash, cash equivalents, and short-term investments were $266.5 million as of March 31, 2022
Full Year 2022 Outlook

Personalis expects the following for the full year of 2022:

Total company revenue is expected to be in the range of $62.0 million to $67.0 million
Revenue from biopharma and all other customers, excluding the VA MVP, is expected to be in the range of $55.0 million to $60.0 million
Net loss is expected to be in the range of $110.0 million to $115.0 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 4, 2022 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: 3187833. The live webinar can be accessed at View Source

10-Q – Quarterly report [Sections 13 or 15(d)]

Jazz Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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