On November 2, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2023 (Press release, Puma Biotechnology, NOV 2, 2023, View Source [SID1234636787]). Unless otherwise stated, all comparisons are for the third quarter of 2023 compared to the third quarter of 2022.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2023 was $51.6 million, compared to $54.3 million in the third quarter of 2022. Product revenue, net in the first nine months of 2023 was $149.9 million, compared to $146.3 million in the first nine months of 2022.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $5.8 million, or $0.12 per basic and diluted share, for the third quarter of 2023, compared to a net loss of $0.4 million, or $0.01 per basic and diluted share, for the third quarter of 2022. Net income for the first nine months of 2023 was $9.3 million, or $0.20 per basic and diluted share, compared to a net income of $5.6 million, or $0.13 per basic and diluted share, for the first nine months of 2022.

Non-GAAP adjusted net income was $8.3 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2023, compared to $2.5 million, or $0.05 per basic and diluted share, for the third quarter of 2022. Non-GAAP adjusted net income for the first nine months of 2023 was $17.1 million, or $0.36 per basic and diluted share, compared to non-GAAP adjusted net income of $14.8 million, or $0.33 per basic and diluted share, for the first nine months of 2022. Non-GAAP adjusted net income excludes stock-based compensation expenses. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income and GAAP net income (loss) per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the third quarter of 2023 was $10.7 million, compared to net cash provided by operating activities of $17.3 million in the third quarter of 2022. Net cash provided by operating activities for the first nine months of 2023 was $16.6 million, compared to net cash used in operating activities of $23.5 million in the first nine months of 2022. On September 30, 2023, Puma had cash, cash equivalents, and marketable securities of $85.0 million, compared to cash, cash equivalents, and marketable securities of $81.1 million at December 31, 2022.

"We are pleased to report both positive net income and positive cash flow for the third quarter of 2023," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "In addition, we were pleased to report the FDA’s acceptance of our IND for alisertib and their granting of Orphan Drug Designation to alisertib for the treatment of small cell lung cancer, and we look forward to advancing the clinical development of alisertib in this indication."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) initiating a Phase II clinical trial of alisertib in small cell lung cancer (Q4 2023); (ii) conducting a meeting with the FDA to discuss the clinical development and registration pathway for alisertib in hormone receptor positive, HER2-negative breast cancer (Q4 2023); and (iii) initiating a Phase II clinical trial of alisertib in hormone receptor positive, HER2-negative breast cancer (2024)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the third quarter of 2023, total revenue was $56.1 million, of which $51.6 million was product revenue, net and $4.5 million was royalty revenue. This compares to total revenue of $57.1 million in the third quarter of 2022, of which $54.3 million was product revenue, net and $2.8 million was royalty revenue. For the first nine months of 2023, total revenue was $163.5 million, of which $149.9 million was product revenue, net and $13.6 million was royalty revenue. This compares to total revenue of $162.4 million for the first nine months of 2022, of which $146.3 million was product revenue, net, and $16.1 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $47.5 million for the third quarter of 2023, compared to $54.7 million for the third quarter of 2022. Operating costs and expenses in the first nine months of 2023 were $145.7 million, compared to $148.7 million in the first nine months of 2022.

Cost of Sales

Cost of sales was $13.3 million for the third quarter of 2023, compared to $12.5 million for the third quarter of 2022. Cost of sales was $38.4 million for the first nine months of 2023, compared to $38.3 million for the first nine months of 2022. The year-to-date decrease was due to lower royalty expense related primarily to the timing of sales made in China by Puma’s sub-licensee, partially offset by increased intangible amortization related to the $12.5 million paid to Pfizer for meeting a commercial sales milestone as of December 31, 2022.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $22.8 million for the third quarter of 2023, compared to $24.0 million for the third quarter of 2022. SG&A expenses for the first nine months of 2023 were $69.7 million, compared to $64.9 million for the first nine months of 2022. The $4.8 million increase in SG&A expenses for the first nine months of 2023 compared to the first nine months of 2022 resulted from an increase in payroll and related costs of approximately $4.9 million, primarily related to a $2.0 million tax credit under the CARES Act recorded in the second quarter of 2022, salary increases beginning in the first quarter of 2023 and lower turnover during the nine months ended September 30, 2023.

Research and Development Expenses

Research and development (R&D) expenses were $11.4 million for the third quarter of 2023, compared to $11.2 million for the third quarter of 2022. R&D expenses for the first nine months of 2023 were $37.6 million, compared to $38.5 million for the first nine months of 2022. The $0.9 million year-over-year decrease in R&D expenses resulted primarily from a decrease in clinical trial expense of approximately $3.5 million, primarily due to the reduction and closure of clinical trial sites with respect to NERLYNX, partially offset by increases in internal R&D of approximately $3.4 million, due primarily to a $1.8 million tax credit related to the CARES Act recorded during the period ended September 30, 2022, as well as an increase in payroll-related expenses beginning in 2023.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the third quarter of 2023, compared to $2.7 million for the third quarter of 2022. Total other expenses were $8.0 million for the first nine months of 2023, compared to $7.9 million for the first nine months of 2022. The $0.1 million increase for the first nine months of 2023 reflects higher interest rates on our outstanding notes as well as imputed interest on a legal settlement, largely offset by increased interest income.

Fourth Quarter and Full Year 2023 Financial Outlook

Fourth Quarter 2023

Full Year 2023

Product Revenue, Net

$56 million – $59 million

$206 million – $209 million

Royalty Revenue

$16 million – $19 million

$30 million – $32 million

Net Income

$13 million – $16 million

$22 million – $25 million

Gross to Net Adjustment

15.5% – 16.5%

17.5% – 18.0%

Conference Call

Puma Biotechnology will host a conference call to report its third quarter 2023 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, November 2, 2023. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On November 2, 2023 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported financial results for the third quarter and first nine months of 2023 and provided business highlights (Press release, Prothena, NOV 2, 2023, View Source [SID1234636786]).

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"We continue to advance our programs across the pipeline to address devastating neurological and rare peripheral diseases caused by protein dysregulation which affect millions of people and their families worldwide. Our expertise in developing therapeutic approaches that target misfolded proteins to achieve clinical benefit has us well positioned with several expected milestones in the near future. We are excited for initial topline results from our ongoing Phase 1 SAD and MAD clinical trials of PRX012, an anti-amyloid beta antibody, and our IND for PRX123, a dual amyloid beta/tau vaccine, by the end of 2023," said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. "We also look forward to multiple milestones in 2024, including topline results from AFFIRM-AL, our confirmatory Phase 3 clinical trial of birtamimab, the first potential therapy to show a significant survival benefit in patients with Mayo Stage IV AL amyloidosis; Phase 2b results from Roche on prasinezumab; and Phase 2 results from Novo Nordisk on NNC6019."

Third Quarter, Recent Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease (AD)

PRX012, a wholly-owned potential best-in-class, next-generation subcutaneous antibody for the treatment of AD that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency. Robust reduction of brain amyloid plaque has been demonstrated to likely predict clinical benefit for people with early AD. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for PRX012 for the treatment of AD.

•Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trials are ongoing; initial topline data expected by year-end 2023

BMS-986446 (formerly PRX005), a potential best-in-class antibody for the treatment of AD that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal human biology of AD. BMS-986446 is part of a Global Neuroscience Research and Development Collaboration with Bristol Myers Squibb.

•Received $55 million payment from Bristol Myers Squibb for exclusive worldwide license to BMS-986446, optioned in July
•Bristol Myers Squibb reported that Phase 1 data supports rapidly moving BMS-986446 into a Phase 2 clinical trial in first half 2024

PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of AD, is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau
•Investigational new drug (IND) application expected by year-end 2023

Parkinson’s Disease (PD)

Prasinezumab, a potential first-in-class antibody for the treatment of PD designed to target a key epitope within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche
•Roche presented data at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) from the open-label extension of the PASADENA study which shows that prasinezumab slowed the progression of motor deficits (MDS-UPDRS Part III OFF state score) in early-stage PD
•Roche completed enrollment for the Phase 2b PADOVA clinical trial in patients with early PD (NCT04777331); topline results expected in 2024

Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a wholly-owned potential best-in-class amyloid depleter antibody for the treatment of AL amyloidosis designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure. Among patients with AL amyloidosis, a rare, progressive, and fatal disease, newly diagnosed individuals with advanced disease (e.g., Mayo Stage IV) are at the highest risk for early death. Birtamimab has been granted Fast Track Designation by the FDA for the treatment of patients with Mayo Stage IV AL amyloidosis to reduce the risk of mortality and has been granted Orphan Drug Designation by both the FDA and European Medicines Agency.
•Phase 3 VITAL clinical trial data published in June in Blood, the peer-reviewed journal of American Society of Hematology (ASH) (Free ASH Whitepaper)
•Confirmatory Phase 3 AFFIRM-AL clinical trial in patients with Mayo Stage IV AL amyloidosis, under a Special Protocol Assessment (SPA) with the FDA with a primary endpoint of all-cause mortality at a significance level of 0.10, is ongoing (NCT04973137); topline results expected in 2024

ATTR Amyloidosis

NNC6019 (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR cardiomyopathy designed to deplete the pathogenic, non-native forms of the transthyretin (TTR)

protein and is being developed by Novo Nordisk as part of their up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline
•Phase 2 clinical trial in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047); topline results expected in 2024

Third Quarter and First Nine Months of 2023 Financial Results

For the third quarter and first nine months of 2023, Prothena reported net income of $21.9 million and net loss of $79.6 million, respectively, as compared to a net loss of $45.8 million and $123.3 million for the third quarter and first nine months of 2022, respectively. Net income per share on a diluted basis for the third quarter was $0.38 and net loss per share for the first nine months of 2023 was $1.50, as compared to net loss per share of $0.97 and $2.63 for the third quarter and first nine months of 2022, respectively.
Prothena reported total revenue of $84.9 million and $91.1 million for the third quarter and first nine months of 2023, respectively, as compared to total revenue of $1.5 million and $4.0 million for the third quarter and first nine months of 2022, primarily from collaboration revenue from Bristol Myers Squibb. The increase in collaboration revenue in the third quarter and first nine months of 2023 compared to the same periods in the prior year was primarily due to $72.9 million recognized for the tau Global License Agreement ($17.9 million of deferred revenue recognized for the tau global right and $55 million option exercise fee).
Research and development (R&D) expenses totaled $57.9 million and $158.7 million for the third quarter and first nine months of 2023, as compared to $39.9 million and $98.7 million for the third quarter and first nine months of 2022, respectively. The increase in R&D expense for the third quarter and first nine months of 2023 compared to the same periods in the prior year was primarily due to higher clinical trial expenses, higher personnel related expenses and higher consulting offset in part by lower manufacturing expenses. R&D expenses included non-cash share-based compensation expense of $4.9 million and $14.2 million for the third quarter and first nine months of 2023, as compared to $4.2 million and $11.3 million for the third quarter and first nine months of 2022, respectively.
General and administrative (G&A) expenses totaled $16.6 million and $44.9 million for the third quarter and first nine months of 2023, as compared to $12.0 million and $36.8 million for the third quarter and first nine months of 2022, respectively. The increase in G&A expenses for the third quarter and first nine months of 2023 compared to the same periods in the prior year was primarily related to higher personnel related expenses. G&A expenses included non-cash share-based compensation expense of $6.0 million and $15.7 million for the third quarter and first nine months of 2023, as compared to $3.8 million and $12.6 million for the third quarter and first nine months of 2022, respectively.
Total non-cash share-based compensation expense was $10.9 million and $29.8 million for the third quarter and first nine months of 2023, as compared to $8.0 million and $23.9 million for the third quarter and first nine months of 2022.

As of September 30, 2023, Prothena had $673.1 million in cash, cash equivalents and restricted cash, and no debt.
As of October 26, 2023, Prothena had approximately 53.7 million ordinary shares outstanding.

2023 Financial Guidance

The Company continues to expect the full year 2023 net cash used in operating and investing activities to be $148 to $161 million and expects to end the year with approximately $600 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2023 net cash used in operating and investing activities is primarily driven by an estimated net loss of $153 to $171 million, which includes an estimated $42 million of non-cash share-based compensation expense.

About the Global Neuroscience Research and Development Collaboration with Bristol Myers Squibb

This global neuroscience research and development collaboration is focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target. BMS-986446 (PRX005) is designed to be a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of Alzheimer’s disease and is the first program to advance to the clinic from this collaboration. Prothena is eligible to receive up to an additional $160 million for U.S. rights, up to an additional $110 million for global rights, and up to $1.7 billion for regulatory and commercial milestone payments for a total of up to $2.2 billion, which also includes amounts received to date, plus potential tiered commercial sales royalties across multiple programs.

On November 2, 2023 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Protagonist, NOV 2, 2023, View Source [SID1234636785]).

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"In the third quarter of 2023, Protagonist continued to make rapid progress with its key programs," said Dinesh V. Patel, Ph.D., the Company’s President and CEO. "Positive Phase 2b data from the FRONTIER 1 study with JNJ-2113, established it as a first- and only-in-class oral IL-23 receptor antagonist peptide and triggered the decision to progress into several advanced studies for broad clinical development. In October 2023, Janssen initiated two Phase 3 psoriasis studies, and a Phase 2b ulcerative colitis study, and plans to undertake additional Phase 3 psoriasis studies in the first quarter of next year. The extraordinary pace of progress in multiple indications reflects strong confidence in JNJ-2113’s potential to have a meaningful impact on these and other diseases mediated by the IL-23 pathway."

Dr. Patel continued: "We are equally excited about the potential of rusfertide, currently in the Phase 3 VERIFY study, to transform the treatment paradigm for polycythemia vera. We are very pleased with the continuing level of enthusiasm among PV-treating physicians and patients participating in the ongoing Phase 3 VERIFY study and look forward to sharing our latest findings in Polycythemia Vera and from our ongoing studies through five oral and poster presentations at the upcoming ASH (Free ASH Whitepaper)2023 Annual Meeting."

1 Based on $322.7 million in cash, cash equivalents and marketable securities as of September 30, 2023 and including expected $60.0 million in JNJ-2113 milestones.

Q3 and Recent Corporate Highlights

· Positive Phase 2b FRONTIER 1 topline results were presented at the World Congress of Dermatology in Singapore in July 2023. All primary and secondary efficacy endpoints were achieved in the study, which evaluated five different dosing regimens of JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis. JNJ-2113 is a novel oral IL-23R antagonist peptide which binds with high affinity to the IL-23 receptor.
· Following positive data from the FRONTIER 1 study, advanced clinical studies in multiple indications were announced and recently initiated:

§ ICONIC-LEAD is a randomized controlled Phase 3 trial to evaluate the safety and efficacy of JNJ-2113 compared with placebo in participants with moderate-to-severe plaque psoriasis, with PASI-90 and IGA score of 0 or 1 as co-primary endpoints.
§ ICONIC-TOTAL is a randomized controlled Phase 3 trial to evaluate the efficacy and safety of JNJ-2113 compared with placebo for the treatment of plaque psoriasis in participants with at least moderate severity affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet) with overall IGA score of 0 or 1 as the primary end point.
§ ANTHEM-UC is a Phase 2b randomized control trial to evaluate the safety and effectiveness of JNJ-2113 compared with placebo in patients with moderately to severely active ulcerative colitis.

· Dosing of the third patient in the ICONIC-LEAD Phase 3 trial in late October 2023 earned Protagonist a $50 million milestone from Janssen Biotech, Inc. under the terms of the licensing and collaboration agreement between both companies.
· Five abstracts related to rusfertide, an investigational hepcidin mimetic, were accepted for oral or poster presentation at ASH (Free ASH Whitepaper)2023, as follows:

Oral presentations

§ Title: Real-World Analysis of Thromboembolic Event Rates in Patients in the United States with Polycythemia Vera. Presenting author: Andrew T. Kuykendall, MD (Moffitt Cancer Center, Tampa, FL).
§ Title: Durability of Hematocrit Control in Polycythemia Vera with the First-in-Class Hepcidin Mimetic Rusfertide: Two-Year Follow up Results from the Revive Study. Presenting author: Ellen K. Ritchie, MD (Weill Cornell Medical College New York Presbyterian, NY).

Poster presentations

§ Title: Iron Restricted Erythropoiesis Under Hepcidin Mimetic Treatment (PN23114) Improved Disease Parameters in a Mouse Model for Sickle Cell Disease. Presenting author: Roopa Taranath, PhD (Protagonist Therapeutics, Inc., Newark, CA).
§ Title: Rusfertide Improves Markers of Iron Deficiency in Patients with Polycythemia Vera. Presenting author: Yelena Ginzburg, MD (Mount Sinai, New York, NY).
§ Title: Prevalence of Second Cancers in Patients with Polycythemia Vera (PV): A Retrospective Analysis of US Real-World Claims Data. Presenting author: Naveen Pemmaraju, MD (MD Anderson Cancer Center, Houston, TX).

At the 5th International Congress on Myeloproliferative Neoplasms, held November 2-3, 2023, Dr. Naveen Pemmaraju presented a poster titled, "Summary of Malignancies Observed Across 5 Open Label Clinical Trials of the Hepcidin Mimetic Rusfertide." The poster can be found on the Protagonist corporate website at View Source

Third Quarter 2023 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2023, were $322.7 million.

· License and Collaboration Revenue: License and collaboration revenue was zero for the three and nine months ended September 30, 2023, as we completed our performance obligation associated with the Janssen License and Collaboration Agreement as of June 30, 2022. License and collaboration revenue for the three and nine months ended September 30, 2022, was zero and $26.6 million, respectively. The nine months ended September 30, 2022, included a one-time $25.0 million milestone earned by the Company following the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 clinical trial of JNJ-2113.

· Research and Development ("R&D") Expenses: R&D expenses were $30.7 million and $91.3 million for the three and nine months ended September 30, 2023, respectively, as compared to $25.4 million and $96.3 million for the same periods in 2022. The increase in R&D expenses from the prior year quarter was primarily due to an increase in rusfertide expenses related to the Phase 3 VERIFY clinical trial, partially offset by a decrease in PN-943 expenses. The decrease in R&D expenses from the prior year was primarily due to decreases in PN-943 expenses and costs related to preclinical and discovery research, partially offset by an increase in rusfertide expenses.

· General and Administrative ("G&A") Expenses: G&A expenses were $7.7 million and $25.4 million for the three and nine months ended September 30, 2023, respectively, as compared to $6.9 million and $25.1 million for the same periods in 2022. The increase in G&A expenses from the prior year quarter was primarily due to increases in payroll, stock-based compensation, and general expenses.

· Net Loss: Net loss was $34.1 million, or $0.58 per share, for the three months ended September 30, 2023, as compared to a net loss of $31.2 million, or $0.64 per share, for the three months ended September 30, 2022. Net loss was $106.3 million, or $1.91 per share, for the nine months ended September 30, 2023, as compared to a net loss of $93.2 million, or $1.90 per share, for the nine months ended September 30, 2022.

On November 2, 2023 Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, reported that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for their immunotherapy ZH9 (Press release, Prokarium, NOV 2, 2023, View Source [SID1234636784]). The approval enables initiation of the clinical development program for ZH9 in the U.S., focusing on patients with non-muscle invasive bladder cancer.

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"The FDA’s approval of our IND application is an important milestone and a clear recognition of the preclinical data already generated for ZH9," stated Prokarium’s CEO, Kristen Albright, PharmD. "Importantly, it also validates the innovative design of the PARADIGM-1 study, paving the way for collaboration with top-tier research centers in the U.S."

"Urologists are excited to see the emergence of new therapies in clinical development for bladder cancer patients," stated Sam S. Chang, MD, Chief Surgical Officer at the Vanderbilt Ingram Cancer Center. "The urgent and continuous need to prevent bladder cancer recurrence, especially given the ongoing shortage of BCG, the standard treatment option for high-risk patients, makes the development of innovative alternatives a matter of importance."

In a strategic move, Prokarium strengthens their leadership team with the appointment of Dara Henry, PhD, as Chief Operating Officer. Dara brings over two decades of experience in biotech and large pharma. His recent role as an entrepreneur-in-residence at Evotec, and prior senior positions in operations and business development at Achilles Therapeutics and GlaxoSmithKline, demonstrate his commitment to advancing biopharmaceutical innovation.

"Prokarium is uniquely positioned in the biotech landscape with a compelling lead program targeting an underserved population of bladder cancer patients," stated Henry, "and beyond the immediate value of this program, Prokarium’s Living Cures platform has the potential to be a game-changer in the field of immunotherapy, enabling a new generation of highly innovative, off-the-shelf programmable therapeutics."

"I’m excited to welcome Dara to our team during this transformative phase, as Prokarium enters clinical development, solidifying our status as a leader in synthetic biology and immuno-oncology," said Albright.

On November 2, 2023 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 third quarter of 2023 (Press release, Pacira Pharmaceuticals, NOV 2, 2023, View Source;991.htm [SID1234636783]).

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Third Quarter 2023 Financial Highlights

•Total revenues of $163.9 million
•Net product sales of $128.7 million for EXPAREL, $28.8 million for ZILRETTA, and $5.3 million for iovera°
•Net income of $10.9 million, or $0.23 per share (basic and diluted)
•Adjusted EBITDA of $52.9 million

See "Non-GAAP Financial Information" below.

"Pacira continues to operate from a position of financial strength with substantial revenues, improving gross margins, and ongoing operating discipline, which have resulted in significantly positive adjusted EBITDA of $53 million for the third quarter," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Our strong and durable cash flows, fueled by EXPAREL exclusivity through 2041, leave us well positioned to self-fund our growth and deliver multiple value-creating milestones in the coming year including the anticipated launch of EXPAREL in two key lower extremity nerve blocks. Looking ahead, we will continue to actively manage operating expenses while deploying capital in a manner we believe will maximize shareholder return and unlock the significant untapped potential within our best-in-class opioid-sparing commercial portfolio."
Recent Business Highlights
•Four New Independent Directors Appointed to Board of Directors. In October 2023, the company announced the appointments of Marcelo Bigal, MD, PhD, Abraham Ceesay, Michael Yang, and Alethia Young, to its Board of Directors. Each of the new directors adds diversity of experience and background to the Pacira board of directors, while also enhancing racial and gender diversity. Pacira now has 12 experienced directors, all with relevant industry experience.
•New Initiatives Supporting the American Society of Anesthesiologists to Advance Education and Enhance Patient Care. In October 2023, the American Society of Anesthesiologists (ASA) and Pacira announced a new grant from Pacira to the ASA Charitable Foundation to advance the medical specialty of anesthesiology and pain medicine, facilitate best-in-class clinician education and improve patient care. The company has also joined ASA’s Industry Supporter Program to support the Society’s more than 56,000 physician anesthesiologist members to improve patient care and reduce reliance on opioids for the treatment of postsurgical or chronic pain.
•Leadership Succession Plan. In September 2023, the company announced that David Stack will retire from his role as chairman and chief executive officer. To ensure a seamless transition, Mr. Stack has committed to continuing in his current role until a replacement is appointed by the Board of Directors after which Mr. Stack will continue with the company in a consulting role through August 2025.

Third Quarter 2023 Financial Results

•Total revenues were $163.9 million in the third quarter of 2023, versus $167.5 million reported for the third quarter of 2022.
•EXPAREL net product sales were $128.7 million in the third quarter of 2023, versus $132.6 million reported for the third quarter of 2022. Third quarter average daily volume growth of 5 percent was offset by a lower net selling price primarily due to the implementation of 340B Drug Pricing in October 2022 and other contracted relationships. There were 62 selling days in the third quarter of 2023 and 64 selling days in the third quarter of 2022.
•ZILRETTA net product sales were $28.8 million in the third quarter of 2023, versus $26.5 million reported for the third quarter of 2022.
•Third quarter 2023 iovera° net product sales were $5.3 million, versus $4.5 million reported for the third quarter of 2022.
•Sales of bupivacaine liposome injectable suspension to third-party licensees were $0.9 million in the third quarter of 2023, versus $3.0 million reported for the third quarter of 2022.
•Total operating expenses were $146.2 million in both the third quarter of 2023 and 2022.
•Research and development (R&D) expenses were $20.8 million in the third quarter of 2023, compared to $19.4 million in the third quarter of 2022. R&D expenses included $9.4 million and $7.2 million of product development and manufacturing capacity expansion costs in the third quarters of 2023 and 2022, respectively.
•Selling, general and administrative (SG&A) expenses were $67.9 million in the third quarter of 2023, compared to $61.3 million in the third quarter of 2022.
•GAAP net income was $10.9 million, or $0.23 per share (basic and diluted) in the third quarter of 2023, compared to a net loss of $0.7 million, or $(0.02) per share (basic and diluted) in the third quarter of 2022.

•Non-GAAP net income was $36.6 million, or $0.79 per share (basic) and $0.72 per share (diluted) in the third quarter of 2023, compared to $29.9 million, or $0.65 per share (basic) and $0.59 per share (diluted), in the third quarter of 2022.
•Adjusted EBITDA was $52.9 million in the third quarter of 2023, compared to $55.2 million in the third quarter of 2022.
•Pacira ended the third quarter of 2023 with cash, cash equivalents and available-for-sale investments ("cash") of $235.2 million. Cash provided by operations was $44.4 million in the third quarter of 2023, compared to $42.7 million in the third quarter of 2022.
•Pacira had 46.4 million basic and 52.1 million diluted weighted average shares of common stock outstanding in the third quarter of 2023.
See "Non-GAAP Financial Information" below.
Financial Guidance
While the company remains confident in the business and its long-term growth outlook, today it is revising its full-year EXPAREL guidance to reflect an updated view of the remainder of the year. Pacira now expects full-year EXPAREL net product sales of $535 million to $540 million versus the company’s previously guided range of $550 million to $560 million.
Pacira is reiterating the following full-year financial guidance:
•ZILRETTA net product sales of $110 million to $115 million;
•iovera° net product sales of $17 million to $20 million;
•Non-GAAP gross margin of 73% to 74%;
•Non-GAAP R&D expense of $70 million to $80 million;
•Non-GAAP SG&A expense of $220 million to $230 million; and
•Stock-based compensation of $46 million to $49 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, Thursday, November 2, 2023, at 8:30 a.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. 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.