On November 14, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV) reported its financial results for the second quarter ended September 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, NOV 14, 2022, View Source [SID1234624023]).

Roivant’s chief executive officer, Matt Gline, noted: "This has been a great quarter for Roivant. In addition to VTAMA’s strong performance and the enthusiastic feedback we’ve received from patients and providers, we executed our first major PBM contract. This provides immediate coverage for millions of lives associated with that PBM, establishes a national template for unrestricted access to VTAMA, and supports a paradigm shift to VTAMA as the mainstay of psoriasis therapy. Our fully enrolled potentially registrational SLE study for brepocitinib, which reads out next year, and Immunovant’s broadened anti-FcRn portfolio, represent notable progress in our immunology pipeline. Between cost reduction and multiple recent infusions of capital, we’ve extended our runway into the second half of calendar year 2025 – and we’re looking forward to multiple key catalysts between now and then, including many in the next year."

Recent Developments

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•Roivant: On November 8, priced $150 million total gross primary and secondary offering, consisting of gross primary proceeds to Roivant of $100 million. Roivant continued its cost optimization and pipeline reprioritization initiatives initially announced in June 2022 in order to focus capital on the most valuable and meaningful opportunities in the pipeline, while maintaining the financial flexibility to opportunistically in-license assets. Roivant expects that its consolidated cash, cash equivalents and restricted cash of $1.6 billion at September 30, 2022, or $1.9 billion after giving effect to subsequent Roivant and Immunovant follow-on offerings and anticipated proceeds from the sale of Myovant equity rights to Sumitomo Pharma, along with continued cost savings initiatives, support cash runway into second half of calendar year 2025.

•Dermavant: Through November 4, VTAMA has had over 54,000 prescriptions written by approximately 6,400 unique prescribers, based on IQVIA data. For the quarter ended September 30, 2022, Roivant reported VTAMA net product revenue of $5.0 million, representing a gross-to-net yield of approximately 12%. Dermavant also entered into a reimbursement contract with one of the three largest PBMs, effective October 1, 2022. Finally, Dermavant announced results from its maximal use pharmacokinetic study of VTAMA in atopic dermatitis, which showed minimal to no systemic absorption and favorable tolerability when used in pediatric patients down to age two.

•Priovant: Completed enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. With over 1,000 patients exposed in these studies, brepocitinib showed a safety and tolerability profile in line with other class agents. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single potentially registrational Phase 3 trial.

•Immunovant: At Roivant’s Investor Day on September 28, Immunovant unveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL levels in a head-to-head animal study with batoclimab and placebo. Additionally, on September 7 Immunovant unveiled two new development programs for batoclimab in Graves’ disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Immunovant also completed a $75.0 million follow-on offering in October, with leading life sciences investors including Logos Capital, Deep Track Capital, Frazier Life Sciences, TCGX, BVF Partners, and Commodore Capital participating.

•Genevant: On November 2, the federal district court in Delaware issued an opinion and order in the patent infringement suit brought by Genevant and Arbutus against Moderna. The court denied Moderna’s partial motion to dismiss the suit based on the government-contractor defense under 28 U.S.C. Section 1498, which was an attempt by Moderna to shift liability for an unspecified portion its alleged infringement to the US government and taxpayers. The case is now expected to proceed to the pre-trial discovery phase.

•Proteovant: Disclosed today data from its preclinical estrogen receptor (ER) degrader demonstrating equal or better tumor reduction in an in vivo model in a head-to-head comparison with the most advanced degrader in its class.

•Affivant: Affivant and Affimed jointly unveiled AFVT-2101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Boston on November 8. AFVT-2101 is a tetravalent, bispecific ICE (innate cell engager) that selectively targets folate receptor alpha (FRα) and CD16A (FcγR3A). AFVT-2101 directs innate immune cells to kill tumor cells selectively and potently with a wide range of FRα expression. Due to the high avidity for CD16A, AFVT-2101 is more efficacious and potent in both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays than farletuzumab, a monoclonal antibody targeting FRα.

Major Upcoming Milestones

•Dermavant: Expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.

•Priovant: Plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.

•Immunovant: Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and expects to have top-line results from the MG trial in the second half of calendar year 2024 and from the two TED trials in the first half of calendar year 2025. A pivotal Phase 2b trial in CIDP is planned to be initiated by the end of calendar year 2022, with initial results from the open label period expected in the first half of calendar year 2024. In Graves’ disease, a Phase 2 trial is planned to be initiated in early calendar year 2023 with initial results expected in the second half of calendar year 2023. Immunovant plans to finalize the lead asset and trial design in WAIHA following an expected engagement with the hematology division of the FDA before the end of calendar year 2022. Immunovant plans to submit an IND and initiate a Phase 1 study for IMVT-1402 in early 2023 with initial human data expected in mid-2023; Immunovant believes these Phase 1 results together with strong IgG biomarker data from batoclimab may accelerate the development program for 1402.

•Hemavant: Plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.

•Kinevant: Plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.

Second Quarter Ended September 30, 2022 Financial Summary

Cash Position

As of September 30, 2022, we had cash, cash equivalents and restricted cash of approximately $1.6 billion. Giving effect to Immunovant’s October 2022 follow-on offering for $75 million in gross proceeds, Roivant’s November follow-on offering for $100 million in gross primary proceeds, and $115 million in expected proceeds from the planned sale of the Myovant top-up shares in connection with the pending acquisition of Myovant by Sumitomo Pharma, Roivant’s consolidated cash, cash equivalents and restricted cash would have been approximately $1.9 billion. The Myovant transaction is expected to close in the first calendar quarter of 2023, subject to customary closing conditions.

Research and Development Expenses

Research and development (R&D) expenses were $132.0 million for the three months ended September 30, 2022 compared to $132.1 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was offset by increases in personnel-related expenses and program-specific costs, reflecting the progression of our programs and drug discovery. Non-GAAP R&D expenses were $123.3 million for the three months ended September 30, 2022 compared to $103.2 million for the three months ended September 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $157.7 million for the three months ended September 30, 2022 compared to $437.8 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense, partially offset by higher selling, general and administrative expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was partially offset by continued vesting of the equity instruments. Non-GAAP SG&A expenses were $101.5 million for the three months ended September 30, 2022 compared to $68.0 million for the three months ended September 30, 2021.

Net Loss

Net loss was $315.9 million for the three months ended September 30, 2022 compared to $225.6 million for the three months ended September 30, 2021. On a per common share basis, net loss was $0.42 for the three months ended September 30, 2022 and $0.32 for the three months ended September 30, 2021. Non-GAAP net loss was $226.8 million for the three months ended September 30, 2022 compared to $290.0 million for the three months ended September 30, 2021.

(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(2) Represents non-cash share-based compensation expense.

(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.

(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(7) Represents the one-time gain on termination of the options held by Sumitomo Dainippon Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(8) Represents the one-time gain on deconsolidation of a subsidiary.

(9) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three and six months ended September 30, 2022. For the three and six months ended September 30, 2021, acquired IPR&D expense was $122.2 million and $122.3 million, respectively.

Roivant also announced today that it will participate in three additional upcoming investor conferences:

Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference in Miami from December 7-8. CFO Richard Pulik will participate in the panel "Commercial Successes, Current & Upcoming Launches" at 9:00 a.m. EST on Thursday, December 8

Jefferies Healthcare Summit in Denver from December 14-15

41st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. EST on Monday, November 14, 2022 to report its financial results for the fiscal quarter ended September 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On November 14, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform, reported its financial results for the quarter ended September 30, 2022 (Press release, Renovorx, NOV 14, 2022, View Source [SID1234624022]).

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"Since our Inception, RenovoRx’s mission has been to develop and refine our innovative therapy platform, RenovoTAMP, for targeted intra-arterial (IA) delivery of chemotherapy directly to difficult-to-treat solid tumors with the vision of disrupting the current standard of care," said Shaun Bagai, CEO of RenovoRx. "In Q4 of this year, we are anticipating our most significant milestone to date; the first prospective interim analysis of our Phase III TIGeR-PaC clinical trial. The results of this trial have the potential to revolutionize pancreatic cancer treatment, shifting patient focus from coping with their chemotherapy treatment and its typical harsh side effects, to spending more quality time with their family and loved ones. Additionally, the interim analysis will provide us with an important insight into RenovoTAMP and its possibilities as a therapeutic platform. We also anticipate the launch of our second clinical trial in extrahepatic cholangiocarcinoma (eCCA) in Q4 2022/Q1 2023. This will be an integral step in RenovoRx’s growth trajectory, demonstrating the ability of our therapy platform on another difficult-to-treat and aggressive form of cancer."

Mr. Bagai continued, "I am confident in the team we have in place, especially with the recent addition of Angela Gill Nelms as our COO. Angela’s experience and expertise in clinical trial management, driving innovation, and building high-functioning teams has already proven to be invaluable. This is an exciting time to be a part of the RenovoRx team as we continue to be laser-focused on advancing our Phase III TIGeR-PaC clinical trial, launching our Phase II/III clinical trial in eCCA, and expanding our clinical pipeline to fight difficult-to-treat cancers."

Financial Highlights for the Quarter Ended September 30, 2022

●As of September 30, 2022, the Company had cash and cash equivalents and short-term marketable securities of $8.1 million.
●Research and development expenses were $0.8 million for the quarters ended September 30, 2022, and September 30, 2021, respectively. Clinical consulting expenses increased $0.2 million including preclinical research and development and regulatory expenses of $0.2 million which was offset by a decrease in the Phase III TIGeR-PaC clinical trial costs of $0.4 million compared to the quarter ended September 30, 2021.
●General and administrative expenses were $1.3 million for the quarter ended on September 30, 2022, compared to $0.6 million for the quarter ended on September 30, 2021. This $0.7 million increase was primarily due to a $0.3 million increase in professional and consulting services, including legal fees, related to post-IPO support, $0.2 million increase for higher personnel related costs and $0.2 million for directors’ and officers’ liability premiums.
●Net loss was $2.1 million for the quarter ended on September 30, 2022, compared to a net loss of $1.5 million for Q3 ended September 30, 2021.
●As of September 30, 2022, the Company had 9,072,263 common shares outstanding.

About the Phase III TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase III study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On November 14, 2022 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.66 per share, payable on February 1, 2023 to shareholders of record of Quest Diagnostics common stock on January 18, 2023 (Press release, Quest Diagnostics, NOV 14, 2022, View Source [SID1234624020]).

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On November 14, 2022 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported financial results for the third quarter ended September 30, 2022 and provided an update on recent clinical and development pipeline progress (Press release, Prelude Therapeutics, NOV 14, 2022, View Source [SID1234624019]).

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"We made meaningful advancements in the third quarter and to date in the fourth quarter, including FDA clearance for two new INDs, one for PRT3645, a next generation, brain penetrant CDK4/6 inhibitor and one for PRT3789, a novel, first-in-class selective SMARCA2 degrader. We’ve also made good progress in the clinical development of our CDK9 inhibitor, PRT2527 and PRT1419, the MCL1 inhibitor," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.

"We continue to expand our highly innovative clinical pipeline. In order to focus resources on bringing compounds with the highest likelihood of success forward, we have decided to discontinue the internal development of our PRMT5 program. While PRT811 demonstrated a best-in-class safety profile and evidence of clinical activity in biomarker-selected patients with glioma and splicing mutated uveal melanoma, our prioritization reflects the high benchmark we set for clinical and regulatory success," Dr. Vaddi added. "We are committed to delivering impactful medicines to patients and building significant and sustainable value."

"Since joining Prelude, I have had the opportunity to critically review and to assess each program and identify clear next steps for clinical development," said Jane Huang, M.D., President and Chief Medical Officer of Prelude. "With this prioritization, we believe we can generate proof-of-concept clinical data in the next 12 to 24 months to guide our future regulatory pathways to approval. Our CDK9 and MCL1 inhibitors are selective and potent, with potentially superior safety profiles. PRT3645 was specifically designed to be a brain penetrant CDK4/6 inhibitor and our SMARCA2 molecule is a unique, first-in-class degrader, targeting specific patient populations. I believe these programs offer the best chance to improve patient outcomes and I share our investigators’ excitement in our highly differentiated molecules."

Recent Highlights and Upcoming Objectives

CDK9 Inhibitor Program: Given the compelling clinical activity recently reported with CDK9 inhibitors, PRT2527, as a more selective compound, has the potential to be best-in-class, with a favorable toxicity profile, allowing for rapid development in combinations. The PRT2527 Phase 1 dose escalation study in solid tumors has enrolled 11 patients to date. Dose dependent increases in exposure and target engagement were observed as evidenced by MYC and MCL1 depletion to levels associated with tumor regression in preclinical models. No adverse events leading to dose reduction or discontinuation have been reported. The Company remains on track to select a recommended Phase 2 dose by year-end. Prelude will use these safety data to continue cohort expansion in solid tumors, as well as to inform and rapidly progress the hematology trial.
ASH 2022: oral preclinical presentation
Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Targeting BH3, BTK, and CDK: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Anti-Leukemic Activity in Preclinical Primary Models of Human B-ALL, T-ALL, and CLL
Session Date: Saturday, December 10, 2022
Session Time: 2:00 PM – 3:30 PM
Presentation Time: 3:15 PM
Room: Ernest N. Morial Convention Center, 388-390
Present solid tumor dose escalation data at a medical conference in 1H 2023
RP2D in hematological malignancies in 2H 2023
Present initial clinical results for hematological malignancies at a medical conference in 2H 2023
MCL1 Inhibitor Program: To date, 26 patients have been enrolled in the PRT1419 Phase 1 solid tumor dose escalation and confirmation cohorts, including 15 patients at the recommended expansion dose of 80 mg/m2. PRT1419 has demonstrated a differentiated profile with no cardiotoxicity observed in patients to date. Cardiovascular parameters including troponin levels and ejection fraction changes were evaluated, in addition to standard safety, pharmacokinetics and target engagement metrics. The clinical pharmacodynamic profile of PRT1419 demonstrates the desired level of target engagement, as measured by caspase activation in peripheral mononuclear cells and reduction of CD14+ monocytes to levels associated with tumor regressions in preclinical models of hematological cancers. Advancement in hematological cancers will include monotherapy expansions in CLL and NHL based on a strong rationale for MCL1 inhibition and the need for novel treatments in second line.
Solid tumor data is expected to be presented at a medical conference 1H 2023
RP2D expected in hematological malignancies in 2H 2023
Hematological malignancy data expected to be presented in 2H 2023
Brain Penetrant CDK4/6: Phase 1 clinical trial is being initiated for PRT3645 in biomarker enriched patients with select tumor types including sarcomas, mesothelioma, gliomas, head and neck cancers and non-small cell lung cancer, in addition to breast cancer with or without brain metastases.
Present initial clinical results at a medical conference in 2H 2023
RP2D in solid tumors in 2H 2024

SMARCA2/BRM Protein Degrader Program: Prelude received IND clearance in October for PRT3879. Prelude plans to dose the first patient in Q1 2023. SMARCA2 inhibition has the greatest potential in patients with SMARCA4 deficient cancers, including up to 10% of all non-small cell lung cancers.
Provide Clinical update 2H 2023
PRMT5 Programs: In the Phase 1 trials for PRT543 and PRT811, both molecules were generally well tolerated. In the PRT811 clinical trial, a total of 82 patients across multiple tumor types were enrolled in dose escalation and expansion, of whom 57 had glioma or uveal melanoma. Out of 38 glioma patients (16 IDH+ and 22 IDH-), two complete responses were observed in IDH+ glioma. These responses remain ongoing for 62 and 21 weeks, respectively. In addition, out of 19 uveal melanoma patients (8 SPLC+ and 11 SPLC-), one confirmed PR (duration of response of 42 weeks) and a second ongoing unconfirmed PR were observed, both in patients who were SPLC+. The most common adverse events of any grade, with an incidence of >20% were nausea (57.3%), vomiting (41.5%) fatigue (31.7%), constipation (25.6%), and thrombocytopenia (24.4%), and were predominantly grade 1-2. The most common adverse events (grade ≥3), occurring >5% were thrombocytopenia (9.76%), anemia (7.32%), and fatigue (7.32%). Full results from the two clinical trials will be shared in the first half of 2023.
Third Quarter 2022 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents, and marketable securities as of September 30, 2022, were $224.0 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to fund Prelude’s operations into the fourth quarter of 2024.

Research and Development (R&D) Expenses: For the third quarter of 2022, R&D expenses increased to $22.9 million for the three months ended September 30, 2022, from $22.7 million for the three months ended September 30, 2021. Included in research and development expenses for the quarter ending September 30, 2022, was $3.2 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $3.3 million for the three months ended September 30, 2021. Research and development expenses remain steady as our clinical pipeline advances into clinical trials. We expect our research and development expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

General and Administrative (G&A) Expenses: For the third quarter of 2022, G&A expenses decreased to $7.5 million for the three months ended September 30, 2022, from $8.1 million for the three months ended September 30, 2021. Included in the general and administrative expenses for the quarter ended September 30, 2022, was $3.2 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $3.8 million for the same period in 2021. The decrease in general and administrative expenses was primarily due to non-cash stock-based compensation expense and prudent management of expenses.

Net Loss: For the three months ended September 30, 2022, net loss was $30.0 million, or $0.63 per share of common stock, basic and diluted compared to $30.7 million, or $0.66 per share, respectively, for the prior year period. Included in the net loss for the quarter ended September 30, 2022, was $6.4 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $7.1 million for the prior year period.

On November 14, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of $54.9 million for the month of October 2022 (Press release, Pacira Pharmaceuticals, NOV 14, 2022, View Source [SID1234624018]). The company’s net product sales include EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

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"We continue to execute from a position of financial strength having recently reported adjusted EBITDA of $55 million in the third quarter of 2022 as EXPAREL continues to drive significant and durable operating cash flows. We remain well positioned for near- and long-term value creation as we grow revenue through increased market penetration, expansion into new indications, and enhanced reimbursement while simultaneously advancing new product development opportunities," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

"Even with continued near-term volatility in the marketplace, we remain confident in steady double-digit growth potential for EXPAREL and our entire portfolio of non-opioid pain management solutions as we expect our newly announced partnerships, such as our agreement with Sevāredent for oral and maxillofacial procedures, to take hold and begin to deliver on the promise of these collaborations. Moving forward, we remain steadfast in executing our strategy and look forward to 2022 being another record year for Pacira," continued Mr. Stack.

October 2022 Preliminary Net Product Sales Highlights

•EXPAREL net product sales were $45.0 million, compared with $42.5 million for October 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of October 2022 were 106 percent of October 2021. There were 21 EXPAREL selling days in October 2022 and October 2021.
•ZILRETTA net product sales were $8.6 million for October 2022. ZILRETTA sales in October 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
•iovera° net product sales were $1.3 million for October 2022, compared with $1.2 million for October 2021.

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° 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. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA to its commercial offering.

The preliminary net product sales included in this press release are preliminary, unaudited and subject to change as certain required adjustments for product discount and rebate programs are finalized after the end of the quarter. This financial information does not present all information necessary for an understanding of the company’s fourth quarter and full-year 2022 financial results. Pacira expects to report its complete financial results for the fourth quarter and full-year 2022 in the first quarter of 2023.