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.

On May 10, 2022 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, reported that company management will participate in the following upcoming investor conferences (Press release, Arrakis Therapeutics, MAY 10, 2022, View Source [SID1234614132]):

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2022 RBC Capital Markets Global Healthcare Conference
Michael Gilman, Ph.D., Chief Executive Officer of Arrakis, will participate in a fireside chat on Tuesday, May 17, 2022 at 10:30 a.m. ET in New York. Company management will also participate in one-on-one meetings.

UBS Global Healthcare Conference 2022
Company management will participate in one-on-one meetings on Monday, May 23, 2022 in New York.

On May 10, 2022 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported the completion of a $35 million Series C funding round (Press release, OncoHost, MAY 10, 2022, View Source [SID1234614149]). The funding will go towards expanding OncoHost’s ongoing multicenter PROPHETIC trial which utilizes PROphet, the company’s machine learning-based host response profiling platform, and supporting the imminent U.S. commercial launch of the precision oncology diagnostic solution.

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Leveraging advanced proteomic analysis and AI-based host response science, OncoHost’s PROphet platform is a personalized, real-time, dynamic ‘disease navigator’ that provides early identification of an individual’s responsiveness to cancer therapy, analysis of treatment resistance mechanisms, and potential available strategies to overcome this resistance. Clinical trial results have shown PROphet to have remarkably high accuracy in assessing non-small cell lung cancer (NSCLC) patient response at three months, six months and one year. Through one blood test pre-treatment, the company’s multi-patented platform also provides clinicians with potential combination strategies to overcome treatment resistance.

The funding round, which was upsized and oversubscribed, was led by ALIVE Israel HealthTech VC, a pioneer mid-to-late stage healthtech fund. Additional investors included leading Israeli financial firm Leumi Partners, Israel’s largest pension fund Menora Mivtachim, OurCrowd and other existing investors. ALIVE’s co-founder and general managing partner, Prof. Ari Shamiss, was recently named a new member of OncoHost’s board.

"OncoHost provides significant value to both cancer patients and their clinicians and it is an honor to have led this transformational funding round," said Prof. Ari Shamiss, "With promising and significant clinical results, OncoHost’s unique approach can create a brighter and better future for the world of precision oncology, maximizing the likelihood of selecting the correct therapy combinations and dramatically improving therapeutic results for cancer patients. We are confident that Oncohost is set to become a pivotal proteomics market leader in personalized oncology treatment."

"This is OncoHost’s third and most significant investment round to date, demonstrating the company’s maturity, credibility and scalability," said Dr. Ofer Sharon, CEO of OncoHost. "We are honored to be supported by leading local and global investment funds that understand and support our vision to shift the landscape of oncology to a truly personalized approach and want to be part of our journey in revolutionizing cancer care."

OncoHost continues to open additional clinical trial sites around the world and will be expanding its research to further cancer indications. PROphet is set to commercial launch in the U.S. in the third quarter of 2022.

On May 10, 2022 Kyowa Kirin Co., Ltd. reported that Consolidated Financial Summary (IFRS) Fiscal 2022 First Quarter(Press release, Kyowa Hakko Kirin, MAY 10, 2022, View Source [SID1234614019])

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1. Consolidated Financial Results for the Three Months Ended March 31, 2022
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022)

* Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.
* Notice regarding the appropriate use of the earnings forecasts and other special comments

The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position  Assets as of March 31, 2022, were ¥907.8 billion, a decrease of ¥14.1 billion compared to the end of the previous fiscal year.  Non-current assets increased by ¥5.8 billion compared to the end of the previous fiscal year, to ¥409.4 billion, due mainly to an increase in deferred tax assets.  Current assets were ¥498.4 billion, a decrease of ¥19.9 billion compared to the end of the previous fiscal year, mainly reflecting a decrease in trade and other receivables as well as a decrease in cash and cash equivalents due to the payment of dividends and income taxes.

 Liabilities as of March 31, 2022, were ¥163.4 billion, a decrease of ¥21.3 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables.  Equity as of March 31, 2022, was ¥744.5 billion, an increase of ¥7.3 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc.

As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the first quarter was 82.0%, an increase of 2.0 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the three months ended March 31, 2022 (January 1, 2022 to March 31, 2022), revenue was ¥87.8 billion (up 8.2% compared to the same period of the previous fiscal year), and core operating profit was ¥17.3 billion (up 11.8%). Profit attributable to owners of parent was ¥16.0 billion (up 24.1%).

 The increase in revenue was the result of growth of global strategic products in North America and EMEA and a rise in revenue from technology out-licensing, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥3.6 billion.
 Core operating profit rose, despite increases in selling, general and administrative expenses and research and development expenses, due to higher gross profit resulting from an increase in overseas revenue and a rise in revenue from technology out-licensing. The positive effect on core operating profit from foreign exchange was ¥1.2 billion.  Profit attributable to owners of parent increased as a result of an increase in finance income and a decrease in income tax expense in addition to an increase in core operating profit.

On May 10, 2022 Theratechnologies Inc. ("Theratechnologies" or "the Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that initiated enrollment of patients in the basket portion of the first-in-human study of TH1902, Theratechnologies’ investigational lead peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers (Press release, Theratechnologies, MAY 10, 2022, View Source [SID1234614053]).

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Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies, noted, "We are pleased to move forward to the next stage of development of TH1902, the basket portion of the first-in-human study. We firmly believe that the unique mechanism of entry of TH1902 in cancer cells is a key advantage to improve the therapeutic window of docetaxel. TH1902’s targeted delivery and rapid internationalization in cancer cells via the Sortilin receptor enables the potential to accumulate 7.5 to 10 times more docetaxel in cancer cells — as compared to the administration of docetaxel alone. Based on the pre-clinical results obtained so far, we are optimistic in the development of a first-in-class and promising treatment for patients with Sortilin positive solid tumors. Additionally, we continue to advance the development of our SORT1+ TechnologyTM platform by conjugating our proprietary peptide with other effective anti-cancer agents."

Based on the data of the dose escalation part of the study, the dose of TH1902 for the expansion study was established at 300 mg/m2 or 1.5 times the therapeutic dose of docetaxel alone. No dose limiting toxicities were observed following the completion of the first cycle in the last 6 patients treated at 300 mg/m2. The basket portion of the first-in-human study is an expansion study designed to assess TH1902 as monotherapy treatment of advanced refractory or resistant solid tumor types expressing high levels of Sortilin, including Hormone Receptor-positive (HR+) Breast Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, and Melanoma with approximately 10 patients per tumor type. One arm will include a mix of tumor types including Thyroid, Small Cell Lung, Prostate and potential other high Sortilin expressing cancers with approximately 15 patients in total. In addition to evaluating the anti-tumor activity of TH1902, the study will continue to evaluate the safety and pharmacokinetics of TH1902. Exploratory pharmacodynamic and biomarker analyses will also be conducted.

About TH1902
TH1902 is Theratechnologies’ proprietary peptide drug conjugate (PDC) linked to docetaxel, a well-established and well-characterized cytotoxic agent. TH1902 is being developed as a single agent for the treatment of all advanced solid tumors expressing sortilin that are refractory to standard therapy. TH1902 is the Company’s lead PDC drug candidate stemming from Theratechnologies’ SORT1+ Technology in oncology.

About SORT1+ TechnologyTM
Theratechnologies has developed a peptide which specifically targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian, triple negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.

Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies’ investigational novel peptides to specifically target sortilin receptors with the aim of improving the efficacy and safety of those agents.

What is a basket trial?
A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In basket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer. Basket trials may allow new drugs to be tested and approved more quickly than traditional clinical trials. Basket trials may also be useful for studying rare cancers and cancers with rare genetic changes.