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Aurinia Reports First Quarter 2022 Financial and Operational Results

On May 10, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company reported its financial results for the first quarter ended March 31, 2022 (Press release, Aurinia Pharmaceuticals, MAY 10, 2022, View Source [SID1234614116]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Net product revenues were $21.6 million for the quarter ended March 31, 2022, compared to $914 thousand in the prior year period, reflecting FDA approval of LUPKYNIS in late January 2021.

"As previously reported on our fourth quarter call, LUPKYNIS revenues in the first quarter were impacted by care disruptions to both patients and the healthcare system caused by the COVID-19 Omicron variant. We are quite pleased that exiting the quarter, as Omicron abated, we began to see a significant increase in prescribing, patient starts, and refills, leading to a monthly record for received patient start forms and patient starts in March," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Heading into the second half of the year, in addition to expected growth in LUPKYNIS revenues, we look forward to multiple expected corporate milestones, including potential European LUPKYNIS approval, the presentation of additional clinical data sets and continued development progress with our pipeline products, AUR200 and AUR300."

For fiscal year 2022, the Company maintains its net revenue guidance of $115 million to $135 million from sales of LUPKYNIS. This range is based on assumptions regarding the impact of COVID-19 on the current business environment and represents an increase of more than 150 to 200% in net revenue from sales of LUPKYNIS compared to fiscal year 2021. Aurinia’s guidance does not include any potential milestone payments, royalties or contract manufacturing revenue related to the Company’s licensing agreement with Otsuka Pharmaceutical or associated with the marketing of voclosporin in the European Union or Japan.

First Quarter 2022 and Recent Highlights & Upcoming Milestones:

Aurinia added 461 patient start forms (PSFs) during the first quarter 2022, as compared to 257 in the first quarter 2021.
As of Friday, May 6, 2022, the Company recorded 647 total PSFs since January 1, 2022.
PSF conversion rates are now at 80% after 90 days; confirmed patient access to LUPKYNIS through payors and plans remains steady representing about 90% of U.S. total lives.
There were approximately 1,071 patients on LUPKYNIS therapy at March 31, 2022, compared with 884 at the end of 2021. At 6 months post-treatment-start, an average of approximately 70% of patients remain on treatment.
Per recent healthcare provider (HCP) surveys, unaided brand awareness of LUPKYNIS is over 70% while aided brand awareness is over 90% and intent to use in the next 3 months is over 70%, the highest level since launch.
The first presentations of final AURORA 2 continuation study data are expected at the 59th European Renal Association (ERA) Congress and at the European Congress of Rheumatology at the end of May, 2022 and at the European Alliance of Associations for Rheumatology (EULAR) 2022 in June. Submission of a manuscript with the full results is expected in the second half of 2022.
With the start of the year, the Aurinia commercial team initiated several new HCP and patient-targeted marketing programs that include the AURORA 2 data and patient brand ambassadors.
Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a European Commission (EC) approval decision expected in second half of 2022.
Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry is continuing.
Financial Liquidity at March 31, 2022

As of March 31, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $418.8 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, payments made for our ongoing post approval obligations and advancement of our pipeline, payments associated with inventory purchases to ensure adequate supply to meet forecasted demand and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its current operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, conducting planned research and development (R&D) programs, investing in its pipeline and operating activities for at least the next few years.

Financial Results for the Quarter Ended March 31, 2022

Total net revenue was $21.6 million and $914 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. Net revenues primarily consisted of product revenue, net of adjustments for LUPKYNIS, following FDA approval in late January 2021. Quarter over quarter revenue growth is attributed to continued progress in the launch of LUPKYNIS, driven predominantly by further penetration into the LN market.

Total cost of sales and operating expenses for the quarter ended March 31, 2022 were $59.5 million in comparison to $51.5 million for the quarter ended March 31, 2021.

Cost of sales were $256 thousand and $48 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. The increase was primarily due to the growth of LUPKYNIS sales, in comparison to the prior year period.

Gross margin for the quarters ended March 31, 2022 and March 31, 2021 was approximately 99% and 95% respectively. The fluctuation in gross margin is driven primarily by fixed specialty pharmacy costs in the first quarter of 2021, as a larger percentage of the overall cost of sales in the quarter.

Selling, general and administrative (SG&A) expenses were $45.2 million and $39.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively, which is consistent with the prior quarter and represents a fully burdened quarter, as the Company did not have approval until late January 2021. The increase was primarily due to an increase in employee related expenses, professional fees related to various corporate matters, pharmacovigilance costs and consulting related expenses tied to the increased investment in back office infrastructure to support the commercialization of LUPKYNIS.

Non-cash SG&A share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $6.0 million and $6.6 million, respectively.

R&D expenses were $12.6 million and $9.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively. The primary driver for the increase quarter over quarter was due to an increase in expenses related to AUR200 and AUR300 development, partially offset by a decrease in expenses related to the AURORA 2 continuation study which was completed during the fourth quarter of 2021 but had wind down activities ongoing in the quarter ended March 31, 2022.

Non-cash R&D share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $1.0 million compared to $1.1 million, respectively.

For the quarter ended March 31, 2022, Aurinia recorded a net loss of $37.6 million or $0.27 net loss per common share, as compared to a net loss of $50.4 million or $0.40 net loss per common share for the quarter ended March 31, 2021.

This press release is intended to be read in conjunction with the Company’s unaudited condensed consolidated financial statements and Management’s Discussion and Analysis for the quarter ended March 31, 2022 in the Company’s Quarterly Report on Form 10-Q, which will be accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2022 financial results today, Tuesday, May 10, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (866) 682-6100 / (862) 298-0702 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

Horizon Therapeutics and Chicago Sky Announce Multi-Year Partnership

On May 9, 2022 Horizon Therapeutics (Nasdaq: HZNP) and the Chicago Sky reported a multi-year partnership, which includes robust community programming as well as marketing and branding assets (Press release, Horizon Therapeutics, MAY 10, 2022, View Source [SID1234614114]). As part of the partnership, Horizon will be the presenting sponsor of the newly unveiled Chicago Sky Basketball Academy, as well as one of twelve presenting sponsors of the Sky’s social justice program, Beyond Basketball, which focuses on economic development, youth financial literacy, voting rights and food deserts. The partnership will also include rehabbing a basketball court in an underserved community each season.

"We are proud to partner with the Chicago Sky, an organization that shares our commitment to empowering people in communities throughout the Chicagoland area, home to our U.S. headquarters," said Tim Walbert, chairman, president and chief executive officer, Horizon. "I look forward to building meaningful community initiatives together that advance the understanding and dialogue around pressing societal issues, including education equity and social justice."

"Horizon Therapeutics has changed lives through purposeful and transformative work in science and we’re thrilled to promote the company’s work through this groundbreaking partnership," said Sky CEO and President Adam Fox. "The Sky organization is fortunate to have a committed partner to help us broaden interest in the WNBA, to advance social justice campaigns, and create meaningful change in our communities."

This represents the most recent sports marketing partnership in the Chicagoland area for Horizon, which also includes partnerships with the Chicago Cubs, Chicago Bulls and Chicago Bears. Horizon was also recently named the title partner of the Irish Open in a six-year deal, which will begin with the 2022 Horizon Irish Open at Mount Juliet Estate in County Kilkenny, Ireland, in late June.

Coherus BioSciences Management to Present at Upcoming Investor Conferences

On May 10, 2022 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that senior management will present at the following investor conferences in May (Press release, Coherus Biosciences, MAY 10, 2022, View Source [SID1234614112]).

BofA Securities 2022 Healthcare Conference on Thursday, May 12 at 3:00 p.m. ET
UBS Global Healthcare Conference on Tuesday, May 24 at 2:00 p.m. ET
H.C. Wainwright Global Investment Conference on Wednesday, May 25 at 9:00 a.m. ET
Audio webcasts of these presentations will be available on the investors’ page of the Coherus website at View Source Please access the website prior to the start of the presentation to ensure a timely connection to the webcast. Each webcast will be archived on the Coherus website for 30 days.

Cellectar Reports Financial Results for First Quarter 2022 and Provides a Corporate Update

On May 10, 2022 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Cellectar Biosciences, MAY 10, 2022, View Source [SID1234614111]).

First Quarter and Recent Corporate Highlights

Announced that an independent data monitoring committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned. The DMC is an independent committee of clinical research experts charged with the review of data from the company’s ongoing pivotal trial. The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol.

Announced the appointment of two key executives to its commercial team: Matthew Hagan as vice president marketing and strategic alliances and David Lasecki as executive director, strategic alliances.
"The unanimous agreement of the independent DMC that the pre-specified futility analysis for our pivotal Phase 2b trial of iopofosine I-131 in WM was achieved represents an important milestone," said James Caruso, president and CEO of Cellectar. "We look forward to continuing iopofosine’s clinical development and remain appreciative of the strong support by the patient advocacy groups, community clinicians and WM academic thought leadership as we collectively partner to treat this orphan designated cancer. In multiple myeloma, we continue to enrich our CLOVER-1 trial and are optimistic that iopofosine I-131 will help to address an unmet medical need in this indication."

First Quarter 2022 Financial Highlights

Cash and Cash Equivalents: As of March 31, 2022, the company had cash and cash equivalents of $30.6 million, compared to $35.7 million as of December 31, 2021. Net cash used in operating activities during the three months ended March 31, 2022 was approximately $5.0 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of the first quarter 2022 financial statements.

Research and Development Expense: R&D expense for the three months ended March 31, 2022 was approximately $3.9 million, compared to approximately $4.6 million for the three months ended March 31, 2021. The overall decrease in R&D expense of approximately $746,000 was primarily the result of a reduction in clinical project costs of approximately $1.5 million, partially offset by an increase in manufacturing and related costs related to production sourcing, general research and development costs resulting from an increase in personnel, and pre-clinical project costs.

General and Administrative Expense: G&A expense for the three months ended March 31, 2022 was $2.3 million, compared to $1.7 million for the same period in 2021. The overall increase in G&A expense of $527,000 was primarily driven by an increase in professional fees and personnel costs, including stock-based compensation expense and a resumption of travel.

Net Loss: The net loss attributable to common stockholders for the quarter ended March 31, 2022 was ($6.1) million, or ($0.10) per share, compared to ($6.4) million, or ($0.13) per share, in the quarter ended March 31, 2021.

F-star Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

On May 10, 2022 F-star Therapeutics, Inc. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies to transform the lives of patients with cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, F-star, MAY 10, 2022, View Source [SID1234614110]).

"This year is one of the most important years in F-star’s history, with data readouts expected across all four of our clinical programs, expansion of our partnering activities, and continued development of our organization," said Eliot Forster, CEO of F-star Therapeutics, Inc. "During the quarter, we increased the number of clinical sites for FS118 and FS120 by expanding beyond the US into the EU. We have also further advanced our understanding of the differentiated mechanism of FS118 in modulating LAG-3 cell surface expression. F-star continues to execute and create value for shareholders by advancing our programs and enabling our partners to develop next-generation bispecific therapeutics by leveraging the power of our discovery platform."

First Quarter 2022 and Recent Highlights:

Patients dosed in FS120 and FS118 trials in Europe, adding to the ongoing clinical activities in the US.
Appointment of James Sandy as Chief Development Officer: Mr. Sandy brings over 35 years of experience in the pharmaceutical and biotechnology industries. James brings valuable additional expertise to the team in accelerating cancer treatment programs through early and late-stage development that will greatly benefit our clinical development strategy.
FS118 poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting demonstrating a novel LAG-3 reduction and shedding mechanism: Data revealed that the tetravalent and unique structure of FS118 plays a critical role in evoking LAG-3 shedding and cell surface reduction by tumor-infiltrating lymphocytes (TILs), enabling FS118 to overcome compensatory upregulation of LAG-3 induced by PD-(L)1 blockade.
Fourth licensing option exercised by Merck KGaA, Darmstadt, Germany: Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will be responsible for all future development and commercialization costs of the bispecific program and will pay future success-based milestones and royalties on any net sales resulting from programs covered by the agreement.
IP portfolio expansion with the issuance of U.S. patent further protecting FS118: United States Patent and Trademark Office (USPTO) has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors. U.S. Patent No. 11,214,620 is entitled "Binding Molecules Binding PD-L1 and LAG-3" and is expected to provide F-star with exclusivity for FS118 out to at least August 2038.
Participation in investor conferences: The management team participated in four investor conferences in the first quarter.
Anticipated 2022 Program Milestones:

A clinical efficacy readout of FS118 in PD-1 acquired resistance head and neck cancer patients who have failed checkpoint therapies.
Clinical update on FS222 Phase 1 trial.
Clinical update on the Phase 1 trial of FS120 and initiation of the combination with Merck’s pembrolizumab.
Clinical update of the dose-escalation study of SB 11285.
First-Quarter 2022 Financial Update

Cash Position
Cash and cash equivalents were $68.8 million as of March 31, 2022, compared to $78.5 million at December 31, 2021.

Research & Development Expense
Research & Development (R&D) expenses were $8.0 million for the quarter ended March 31, 2022, compared to $7.1 million for the corresponding quarter in 2021. This increase of $0.9 million in R&D expense is primarily due to increased CRO costs as more patients are enrolled in clinical studies, increased R&D staff related costs primarily to support clinical operations, offset by a reduction in manufacturing costs.

General & Administrative Expense
General & Administrative (G&A) expenses were $5.7 million for the quarter ended March 31, 2022, compared to $6.4 million for the first quarter 2021. The $0.7 million decrease is primarily due to a decrease in stock compensation expense, and legal and professional costs due to costs incurred in the comparative period for work in relation to the share exchange transaction with Spring Bank Pharmaceuticals. These decreases were offset by increases in facilities-related costs and information technology costs.

Net Loss Attributable to Common Shareholders
Net loss attributable to common shareholders was $12.1 million or $0.57 per share, for the quarter ended March 31, 2022, as compared to a net loss of $9.7 million or $1.07 per share for the quarter ended March 31, 2021.

Conference Call and Webcast

F-star will host a conference call today, May 10, 2022, at 9:00 a.m. EDT.

To access the call, participants may join via a live webcast on the Investors & News section of the F-star Therapeutics website, under Events and Presentations. To join by phone, participants may dial the following numbers at least 10 minutes prior to the start of the call:

A replay of the conference call will be available for 90 days from the call and may be accessed in the Investor & News/Events and Presentations section of the F-star Therapeutics website.