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Friday, January 27, 2023

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) Big Move as Co Reports Excellent Year End Financial Results & Reaches Settlement with Sun Pharma over Lupkynis Patent Challange

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) is making a big move up the charts in recent trading since reversing off $4.07 lows in December. Over the past few days AUPH has rocketed up over $7 per share after the Company reached a settlement with India’s Sun Pharmaceuticals over the patent challenge of its lupus nephritis treatment Lupkynis. The two Company’s agreed to file a joint motion to dismiss Inter Parties Review (IPR) of patent number 10,286,036. The lawsuit had been a negative factor on the stock price for both companies, so the settlement was welcome news. AUPH spiked to highs over $34 per share back in 2021 based on  a pervasive buyout rumor but saw significant declines since then ending when the stock reversed of $4.07 52-week lows. 

Aurinia also provided an update on its business performance. Preliminary unaudited net revenue for the three months and full year ended December 31, 2022 was approximately $28.4 million and $134.0 million. Aurinia also had unaudited cash, cash equivalents and restricted cash and investments of approximately $388.7 million as of yearend 2022. Peter Greenleaf, President and Chief Executive Officer of Aurinia, will discuss these updates as part of a webcast presentation at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11 at 4:30 p.m. Pacific Time / 7:30 p.m. Eastern Time in San Francisco, CA. Mr. Greenleaf stated Aurinia is positioned to achieve net revenue guidance from product sales for 2023 in the range of $120-$140 million. We will be updating on AUPH when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) operating out of Victoria, British Colombia, Aurinia is a commercial-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. Aurinia has commercially launched LUPKYNIS in the United States for the treatment of adult patients with active LN. We continue to conduct pre-clinical, clinical, and regulatory activities to support the voclosporin development program as well as our other assets. 

On January 22, 2021, the FDA approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN. 

On August 17, 2021, Aurinia announced the addition of two novel assets, AUR200 and AUR300. AUR200 is currently undergoing pre-clinical development with projected submission of an Investigational New Drug Application (IND) to the FDA in 2023. It is anticipated that an IND for AUR300 will be submitted during the first half of 2023. 

On December 9, 2021, Aurinia announced positive topline results from the AURORA 2 continuation study, evaluating the long-term safety and tolerability of LUPKYNIS. 

LUPKYNIS is an orally administered CNI immunosuppressant, that has demonstrated improvement in near and long-term outcomes in LN when used in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis. By inhibiting calcineurin, LUPKYNIS reduces cytokine activation and blocks interleukin IL-2 expression and T-cell mediated immune responses. LUPKYNIS also potentially stabilizes podocytes, which can protect against proteinuria. Voclosporin, the active ingredient in LUPKYNIS, is made by a modification of a single amino acid of the cyclosporine molecule. The mechanism of action of LUPKYNIS has been validated with certain earlier generation CNIs for the prevention of rejection in patients undergoing solid organ transplants and in several autoimmune indications, including uveitis, keratoconjunctivitis sicca, psoriasis, rheumatoid arthritis, and for LN in Japan. We believe that LUPKYNIS possesses pharmacologic properties with the potential to demonstrate best-in-class differentiation. 

LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN). LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is approved in the United States (U.S.), the United Kingdom and across the European Union (E.U). LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. 

Earlier generation CNIs have demonstrated efficacy for a number of conditions, including transplant and other autoimmune diseases; however, side effects exist which can limit their long-term use and tolerability. Some clinical complications of earlier generation CNIs include hypertension, hyperlipidemia, diabetes, and both acute and chronic nephrotoxicity. 

Based on published data,  Aurinia believes the key potential benefits of LUPKYNIS in the treatment of adult patients with active LN versus marketed CNIs include: 

  • increased potency compared to cyclosporine A, allowing for lower dosing requirements and potentially fewer off-target effects;
  • limited inter- and intra-patient variability, allowing for easier dosing without the need for monitoring blood levels for therapeutic drug monitoring;
  • less cholesterolemia and triglyceridemia than cyclosporine A; and
  • limited incidence of glucose intolerance and new onset diabetes at therapeutic doses compared to tacrolimus.

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AUPH

Aurinia Pipeline: 

AUR200: Recombinant Fc Protein Targeting BAFF/APRIL: AUR200 is a recombinant Fc fusion protein designed to specifically block B-cell Activating Factor, known as BAFF, and A Proliferation-Inducing Ligand, known as APRIL. BAFF and APRIL promote B cell survival and differentiation and have been shown to play a prominent role in the pathogenesis of certain autoimmune and nephrology conditions. AUR200 is currently undergoing pre-clinical development with projected submission of an IND to the FDA in 2023. 

AUR300: M2 macrophage modulation via CD206 binding: AUR300 is a novel peptide therapeutic that modulates M2 macrophages (a type of white blood cells) via the macrophage mannose receptor CD206. Dysregulation of M2 macrophages drives fibrosis. AUR300 acts to reduce M2 dysregulation and decrease inflammatory cytokines, and therefore may have significant clinical applications for autoimmune and fibrotic diseases. It is anticipated that an IND for AUR300 will be submitted in 2023. 

On January 6 Aurinia provided an update on its business performance. Preliminary unaudited net revenue for the three months and full year ended December 31, 2022 was approximately $28.4 million and $134.0 million. As of December 31, 2022, Aurinia had unaudited cash, cash equivalents and restricted cash and investments of approximately $388.7 million. 

Peter Greenleaf, President and Chief Executive Officer of Aurinia, will discuss these updates as part of a webcast presentation at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11 at 4:30 p.m. Pacific Time / 7:30 p.m. Eastern Time in San Francisco, CA. 

Preliminary Fourth Quarter 2022 LUPKYNIS Product Metrics 

  • There were approximately 1,525 patients on LUPKYNIS therapy at December 31, 2022, compared with 1,354 at September 30, 2022. 
  • Aurinia added approximately 406 patient start forms (PSFs) during the fourth quarter 2022, as compared to 374 in the third quarter 2022. 

Aurinia Pharmaceuticals - Rockville, MD - KANE ConstructionAurinia CEO Peter Greenleaf said: “Given strong commercial execution in the fourth quarter, we demonstrated substantial growth in our key metrics for LUPKYNIS, including an increased total number of patients on therapy and an uptick in patient start forms in the back half of the fourth quarter, compared to the monthly average in the third quarter of 2022. Given this progress, we believe we have achieved our 2022 full year net product revenue guidance and are positioned to achieve our net revenue guidance from product sales for 2023 in the range of $120-$140 million.”

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Currently trading at a $1 billion market valuation AUPH os is 142,109,703 shares outstanding. The Company has a very strong balance sheet with $388.7 million in cash, cash equivalents and restricted cash and investments as of yearend 2022, just $40 million in total liabilities on the books and fast-growing revenues of $134.0 million in fiscal 2022. As we said AUPH has reached a settlement with India’s Sun Pharmaceuticals over the patent challenge of its lupus nephritis treatment Lupkynis which takes a huge amount of pressure of the stock. All eyes are now on the upcoming Annual J.P. Morgan Healthcare Conference on Wednesday, January 11 where AUPH CEO Peter Greenleaf will give a webcast presentation.  We will be updating on AUPH when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

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Disclosure: we hold no position in AUPH either long or short and we have not been compensated for this article.

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