On May 4, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the first quarter ended April 4, 2021 (Press release, PerkinElmer, MAY 4, 2021, View Source [SID1234579111]).

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The Company reported GAAP earnings per share from continuing operations of $3.37, as compared to GAAP earnings per share from continuing operations of $0.30 in the first quarter of 2020. GAAP revenue for the quarter was $1.308 billion, as compared to $652 million in the first quarter of 2020. GAAP operating income from continuing operations for the quarter was $468 million, as compared to $45 million for the same period a year ago. GAAP operating profit margin was 35.8% as a percentage of revenue, as compared to 6.8% in the first quarter of 2020.

Adjusted earnings per share from continuing operations for the quarter was $3.72, as compared to $0.67 in the first quarter of 2020. Adjusted revenue for the quarter was $1.309 billion, as compared to $653 million in the first quarter of 2020. Adjusted operating income from continuing operations for the quarter was $542 million, as compared to $100 million for the same period a year ago. Adjusted operating profit margin was 41.4% as a percentage of adjusted revenue, as compared to 15.3% in the first quarter of 2020.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"The first quarter performance reinforces that PerkinElmer is emerging from COVID as a stronger organization top-to-bottom," said Prahlad Singh, president and chief executive officer of PerkinElmer. "Our additional investments in innovation, commercial excellence, and people in 2020 are taking hold and give us increased confidence that we are well positioned to deliver faster growth in both the short and long-term."

Financial Overview by Reporting Segment for the First Quarter

Discovery & Analytical Solutions

First quarter 2021 revenue was $455 million, as compared to $398 million for the first quarter of 2020. Reported revenue increased 14% and organic revenue increased 6% as compared to the first quarter of 2020.
First quarter 2021 operating income from continuing operations was $43 million, as compared to $29 million for the comparable prior period.
First quarter 2021 adjusted operating income was $76 million, as compared to $54 million for the first quarter of 2020.
Diagnostics

First quarter 2021 revenue was $853 million, as compared to $254 million for the first quarter of 2020. Reported revenue increased 236% and organic revenue increased 227% as compared to the first quarter of 2020.
First quarter 2021 operating income from continuing operations was $441 million, as compared to $30 million for the comparable prior period.
First quarter 2021 adjusted operating income was $483 million, as compared to $59 million for the first quarter of 2020.
Initiates Second Quarter and Raises Full Year 2021 Guidance

For the second quarter of 2021, the Company forecasts GAAP revenue of approximately $1.11 billion, GAAP earnings per share from continuing operations of $1.90 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of $2.35.

For the full year of 2021, the Company now forecasts GAAP revenue of $4.37 billion, GAAP earnings per share from continuing operations of $7.77 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of $9.40.

Conference Call Information

The Company will discuss its first quarter 2021 results and its outlook for business trends in a conference call on May 4, 2021 at 5:00 p.m. Eastern Time. To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 7294952.

A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Company’s website for a two-week period beginning approximately two hours after the call.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

On May 4, 2021 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 2021 (Press release, Pacira Pharmaceuticals, MAY 4, 2021, View Source;991.htm [SID1234579110]).

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First Quarter 2021 Financial Highlights

Total revenues of $119.0 million
GAAP net income of $10.4 million, or $0.24 per share (basic) and $0.23 (diluted)
Non-GAAP Adjusted EBITDA of $36.2 million
"2021 is off to a terrific start with notable progress taking place across all areas of our business," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The launch of EXPAREL for pediatric patients is going exceptionally well and already garnering a high level of receptivity and enthusiasm from key opinion leaders at the top children’s hospitals. We continue to see expanding utilization of EXPAREL-based nerve and field blocks as a cornerstone of low- or no-opioid protocols that enable accelerated recovery and surgical migration to the outpatient setting, as evidenced by EXPAREL consistently outpacing the elective surgery market. In addition, commercial enhancements for iovera° are taking hold and driving a substantial increase in sales and ordering accounts."

"The Pacira Innovation and Training Center of Tampa is addressing the market’s significant demand for effective, long-acting opioid-sparing pain management strategies through a robust offering of live and virtual programs for both EXPAREL and iovera°. Looking ahead, we remain well-positioned to continue to deliver strong top- and bottom-line growth as the COVID crisis recedes and the elective surgery market normalizes," concluded Mr. Stack.

First Quarter 2021 Financial Results

Total revenues were $119.0 million in the first quarter of 2021, versus $105.7 million reported for the first quarter of 2020.
EXPAREL net product sales were $114.7 million in the first quarter of 2021, versus $101.3 million reported for the first quarter of 2020.
First quarter 2021 iovera° net product sales were $3.3 million, versus $2.3 million reported for the first quarter of 2020.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $0.8 million in the first quarter of 2021, versus the $1.2 million in the first quarter of 2020.
First quarter 2021 royalty revenues were $0.3 million, versus the $0.9 million in the first quarter of 2020.
Total operating expenses were $99.6 million in the first quarter of 2021, compared to $88.6 million in the first quarter of 2020.
Research and development (R&D) expenses were $15.9 million in the first quarter of 2021, compared to $15.8 million in the first quarter of 2020. R&D expenses include $4.7 million and $6.6 million of product development and manufacturing capacity expansion costs in the first quarters of 2021 and 2020, respectively.
Selling, general and administrative (SG&A) expenses were $48.5 million in the first quarter of 2021, compared to $44.8 million in the first quarter of 2020.
GAAP net income was $10.4 million, or $0.24 per share (basic) and $0.23 (diluted), in the first quarter of 2021, compared to GAAP net income of $8.2 million, or $0.19 per share (basic and diluted), in the first quarter of 2020.
Non-GAAP net income was $24.5 million, or $0.56 per share (basic) and $0.53 (diluted), in the first quarter of 2021, compared to non-GAAP net income of $22.8 million, or $0.54 per share (basic) and $0.53 (diluted), in the first quarter of 2020.
Adjusted EBITDA was $36.2 million in the first quarter of 2021, compared to adjusted EBITDA of $26.9 million in the first quarter of 2020.
Pacira ended the first quarter of 2021 with cash, cash equivalents, short-term and long-term investments ("cash") of $625.0 million. Cash provided by operations was $12.1 million in the first quarter of 2021, compared to $6.2 million in the first quarter of 2020.
Pacira had 43.8 million basic and 46.0 million diluted weighted average shares of common stock outstanding in the first quarter of 2021.
See "Non-GAAP Financial Information" below.

Recent Business Highlights

Investment in Spine BioPharma. In April 2021, Pacira announced a $3.0 million investment in Spine BioPharma in the form of a convertible note. The investment will support the advancement of Spine BioPharma’s lead candidate, Remedisc, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7.0 million investment predicated upon Spine BioPharma achieving certain prespecified milestones.
FDA approval of EXPAREL in pediatric patients 6 years of age and older. In March 2021, the U.S. Food and Drug Administration approved the expansion of the EXPAREL label to include its use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.
Financial Guidance

The company’s 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

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, May 4, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8238109. 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 8238109. 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 and adjusted EBITDA, because such measures exclude acquisition-related (losses) gains, product discontinuation and other; stock-based compensation; amortization of debt discount; amortization of acquired intangible assets, loss on investment, and the tax impact of non-GAAP adjustments.

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 2021 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, including adjusted EBITDA.

On May 4, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported first quarter 2021 financial results and highlighted recent achievements and developments (Press release, Oncorus, MAY 4, 2021, View Source [SID1234579109]).

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"We began 2021 with strong momentum, announcing the buildout of our GMP manufacturing facility which is now well underway, and we continue to advance our ambitious goals on behalf of cancer patients," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus.

Dr. Ashburn further commented, "We continue to enroll patients in a Phase 1 clinical trial of ONCR-177, our lead oncolytic Herpes Simplex Virus (oHSV) clinical candidate, and expect initial interim data later this year. We also anticipate nominating our first two synthetic viral RNA (vRNA) immunotherapy candidates in the first half of 2021. These candidates are comprised of vRNA coding for oncolytic viruses encapsulated within lipid nanoparticles, or LNPs – proprietary technologies developed by the Oncorus team. We have designed this novel approach to enable the systemic, repeat intravenous (IV) administration of viral immunotherapies, the so-called ‘holy grail’ of this modality, to date unattainable. We’re excited to introduce this breakthrough approach and discuss these candidates in more detail at an upcoming virtual investor event."

First Quarter 2021 and Recent Highlights

Enrolling Phase 1 clinical trial of ONCR-177. Oncorus is currently enrolling a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally (iTu) administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177. The trial will determine the recommended Phase 2 dose, as well as investigate ONCR-177’s preliminary anti-tumor activity, alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus has an ongoing clinical trial collaboration with Merck involving KEYTRUDA and anticipates reporting interim data from the Phase 1 trial in the second half of 2021 through the second half of 2022.
Advancing lead Synthetic vRNA Immunotherapy Platform programs toward clinical candidate nomination. Oncorus continues to advance its lead synthetic, IV administered vRNA immunotherapy programs based on the Coxsackievirus A21 (CVA21) and the Seneca Valley Virus (SVV). The company expects to nominate clinical candidates for both programs in the first half of 2021. IV administration of viral immunotherapies is an attractive approach for improving the standard of care for many cancer patients because it allows for all tumors, including micro-metastases, to be directly treated. In addition, it allows for the potential treatment of certain tumors, such as those of the lung, that are less amenable to repeat iTu injection of anti-cancer therapies due to safety and feasibility considerations. Oncorus’ Synthetic vRNA Immunotherapy Platform includes a novel LNP delivery strategy designed to overcome the challenges caused by neutralizing antibodies, which have limited the efficacy of previous industry efforts to treat tumors utilizing IV administration of OVs.
Advancing second oHSV viral immunotherapy candidate, ONCR-GBM. Leveraging its oHSV Platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). The company is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and select a combination of payloads intended to address the specific drivers of immune suppression in brain cancer. Oncorus plans to nominate its ONCR-GBM clinical candidate in the second half of 2021.
Announced buildout of Good Manufacturing Practice (GMP) viral immunotherapy clinical manufacturing facility. In January 2021, Oncorus announced the signing of a 15-year lease to build a state-of-the-art, 88,000 square foot GMP viral immunotherapy clinical manufacturing facility in Andover, Mass. The facility is intended to provide a comprehensive solution for Oncorus’ Chemistry, Manufacturing and Controls (CMC) development needs, enabling the manufacture, quality, control and supply of clinical-grade viral immunotherapies for investigational new drug (IND)-enabling and clinical studies. Oncorus anticipates the first phase of the facility’s buildout will be completed in late 2021, including process development and quality control, with GMP multi-product manufacturing capabilities and full operation commencing in early 2023.
Completed follow-on public offering. In February 2021, Oncorus completed an underwritten public offering of common stock, at a price of $19.00 per share, raising $57.0 million in aggregate gross proceeds.
First Quarter Financial Results

Cash and cash equivalents were $172.6 million as of March 31, 2021 compared to $130.3 million as of December 31, 2020.
Research and development expenses for the quarter ended March 31, 2021 were $8.4 million compared to $5.9 million for the corresponding quarter in 2020. The increase in research and development expenses was mainly attributable to increased rent expense related to the Company’s new manufacturing facility, increased personnel-related expenses, including stock-based compensation, driven by increased headcount and increased clinical trial costs for the Company’s ongoing Phase 1 clinical trial of ONCR-177.
General and administrative expenses for the quarter ended March 31, 2021 were $4.2 million compared to $2.1 million for the corresponding quarter in 2020. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses, including stock-based compensation, driven by increased compensation and increased headcount and increased costs, such as insurance expense and professional and consultant expenses, related to operating as a public company.
Net loss attributable to common stockholders for the quarter ended March 31, 2021 was $12.7 million, or $0.53 per share, compared to a net loss attributable to common stockholders of $10.6 million, or $10.59 per share for the same quarter in 2020. The share and loss per share amounts in the first quarter of 2021 reflect the impact of the company’s IPO, which closed in October 2020, including the conversion of outstanding preferred stock into approximately 15.0 million shares of common stock.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents, Oncorus expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into late 2023.

On May 4, 2021 Obsidian Therapeutics, a biotechnology company pioneering engineered cell and gene therapies, reported that the Company will present at the upcoming 24th American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, which will be hosted virtually May 11-14, 2021 (Press release, Obsidian Therapeutics, MAY 4, 2021, View Source [SID1234579108]).

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The abstract for the poster describes how Obsidian’s cytoTIL15 product (cytoTIL therapy engineered with mbIL15) demonstrates enhanced in vivo performance in the absence of IL-2, paving the way for more durable efficacy and improved safety in patients with solid tumor malignancies, and has been published in Molecular Therapy.

Details of the poster:

Title: cytoTIL therapy engineered with mbIL15 demonstrates enhanced in vivo persistence in the absence of IL-2, paving the way for durable efficacy and improved safety in patients with solid tumor malignancies

Abstract Number: 617

Session: Cancer – Immunotherapy, Cancer Vaccines

Session Date and Time: Tuesday May 11, 2021 8:00 AM – 10:00 AM

Abstract Summary: Tumor-infiltrating lymphocytes (TILs) have generated promising data in clinical trials as therapy for heavily pretreated patients with solid tumor malignancies, such as metastatic melanoma. The IL-2 regimen required for in vivo maintenance of TILs poses significant limitations on application of the therapy. Obsidian’s cytoTIL product is comprised of TILs engineered with membrane bound IL-15 (mbIL15) that is regulatable using a drug responsive domain (DRD) designed via our cytoDRiVE platform. cytoTILs demonstrate enhanced persistence in mice without IL2 compared to conventional TILs with IL2.

Paul Wotton, Chief Executive Officer of Obsidian, commented, "We expect that cytoTIL15 will pave the way for a more potent and persistent TIL product that will not require infusion of IL-2, thereby improving durable efficacy and expanding the pool of eligible patients with metastatic melanoma and other solid tumor malignancies that can be treated with this groundbreaking therapy."

On May 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Tuesday, May 11 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the first quarter ended March 31, 2021 (Press release, Navidea Biopharmaceuticals, MAY 4, 2021, View Source [SID1234579107]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.