AUPH Aurinia Pharmaceuticals Inc

• Achieved $50.3 million in total net revenue and $48.1 million in net product revenue for the first quarter of 2024, representing year over year growth of approximately 46% and 40% respectively, and extending the trend of consistent growth in LUPKYNIS® (voclosporin) sales
• Rapidly completed restructuring while maintaining focus on commercial execution
• Ahead of prior projections, Company expects to be cash flow positive, excluding share repurchases, in second quarter 2024, with estimated cost savings of $50 to $55 million annually
• Company reiterates 2024 net product revenue guidance of $200 to $220 million

Conference call to be hosted today at 8:30 a.m. ET

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the first quarter ended March 31, 2024. Amounts are expressed in U.S. dollars.

Total net revenue was $50.3 million for the three months ended March 31, 2024 and $34.4 million for the same period in 2023. representing growth of approximately 46%. Net product revenue was $48.1 million for the three months ended March 31, 2024 and $34.3 million for the same period in 2023, representing growth of approximately 40%.

Aurinia rapidly completed its corporate restructuring in the first quarter, reducing employee headcount by approximately 25%. The Company discontinued its AUR300 research and development program and is exploring alternative approaches for AUR200 to maintain its development momentum. As previously reported, the Company expects to recognize $50 to $55 million in annual cost savings, with 75% of those savings recognized in 2024, excluding a one-time restructuring charge of approximately $7 million incurred in the first quarter. Following the restructuring, the Company expects total annualized operating expenses on a go-forward basis to be in the range of $185 to $195 million, with cash-based operating expenses of approximately $155 to $165 million.

“We are pleased to be on track to reach positive free cash flows, excluding share repurchases, in the second quarter of 2024, ahead of prior projections, further strengthening our financial position, and with further balance sheet growth, allowing more strategic flexibility for the Company,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “We recently achieved several key milestones, including FDA approval of a label update for LUPKYNIS which now includes long-term efficacy data from our AURORA Clinical Program. We have also launched an innovative new marketing campaign to further educate rheumatologists on the seriousness of lupus nephritis and the urgent need for appropriate treatment. This momentum demonstrates our full commitment to solid execution and driving growth, as we continue in our work of delivering LUPKYNIS to patients in need.”

Earlier this week, Aurinia announced that the FDA has approved a label update for LUPKYNIS that provides physicians with important information to treat and manage their lupus nephritis (LN) patients. Notably, the updated label no longer includes language indicating that the safety and efficacy of LUPKYNIS has not been established beyond one year. The label now includes long-term data from a post-hoc analysis of the AURORA 2 extension study showing that patients receiving LUPKYNIS achieved sustained complete renal response at every time point assessed through three years, compared to mycophenolate mofetil (MMF) and low-dose glucocorticoids alone. Additionally, the updated label now requires quarterly, rather than monthly kidney function assessment after the first year of treatment. The safety profile of LUPKYNIS in the updated label remains unchanged and is aligned with the safety findings in the AURORA Clinical Program.

Aurinia recently launched “Know the Signs,” a disease state education campaign designed to increase awareness among rheumatologists around the severity of LN, the critical need to prioritize kidney health for people with systemic lupus erythematosus (SLE), and to increase screening for LN among people with SLE.

In addition to the Company’s operational execution, Aurinia has also released its 2023 ESG report, which details the holistic approach the Company takes to address environmental, social and governance priorities, including energy and emissions, addressing barriers to care among LN patients, (Diversity, Equity and Inclusion) DE&I practices, employee engagement, and risk management. The full report is available here.

For the fiscal year 2024, the Company maintains its established net product revenue guidance for a range of $200 to $220 million. The guidance range is based on assumptions regarding historical patient start form (PSF) run rates, consistent conversion rates, time to convert, persistency, and pricing.

First Quarter 2024 and Recent Highlights

• There were approximately 2,178 patients on LUPKYNIS therapy as of March 31, 2024, compared to 1,731 as of March 31, 2023.
• In the first quarter, the Company added 448 patient start forms and approximately 148 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy, compared to 466 PSFs in the prior year first quarter, representing significant year-over-year growth.
• From January 1, 2024, through April 28, 2024, the Company added approximately 582 PSFs and approximately 170 new patients from restarts and the hospital channel.
• Conversion rates were sustained, with approximately 85% of PSFs converted to patients on therapy.
• Time to convert was sustained with approximately 60% of patients on therapy by 20 days.
• The overall adherence rate remained high at approximately 87% through the first quarter of 2024.
• Persistency continues to improve, with approximately 56% of patients remaining on therapy at 12 months, 50% at 15 months, and 46% at 18 months.

Financial Results for the Three Months Ended March 31, 2024

Total net revenue was $50.3 million and $34.4 million for the three months ended March 31, 2024 and March 31, 2023, respectively. Net product revenue was $48.1 million and $34.3 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The Company currently sells to two main specialty pharmacies for U.S. commercial sales of LUPKYNIS and pursuant to a collaboration partnership with Otsuka for sales of semi-finished product and license, collaboration and royalty revenue in Otsuka Territories. The increase is primarily due to an increase in product sales to our two specialty pharmacies for LUPKYNIS, driven predominantly by further penetration of the LN market.

This penetration can be demonstrated by a total of 2,178 patients on therapy as of March 31, 2024, compared to 1,731 patients on therapy as of March 31, 2023. The increase in patients was driven by 448 additional patients start forms and 148 new patients who were either restarting LUPKYNIS or receiving it through a hospital pharmacy during the three months ended March 31, 2024, compared to 466 PSFs received during the three months ended March 31, 2023. Additionally, our 12-month persistency rate has increased to 56% at March 31, 2024 from approximately 51% at March 31, 2023.

License, collaboration and royalty revenue was $2.2 million and $0.1 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The increase is due to manufacturing services revenue from Otsuka related to shared capacity services that commenced in the third quarter of 2023.

Total cost of sales and operating expenses, inclusive of a one-time restructuring charge in Q1 2024, were $63.6 million and $64.0 million for the three months ended March 31, 2024 and March 31, 2023, respectively. Further breakdown of cost of sales and operating expense drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $7.8 million and $0.4 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The increase is primarily due to increased sales of LUPKYNIS (voclosporin), coupled with the amortization of the monoplant finance right of use asset, which was placed into service in late June 2023.

Gross margin was approximately 85% and 99% for the three months ended March 31, 2024 and March 31, 2023, respectively.

SG&A expenses, inclusive of share-based compensation, were $47.7 million and $50.1 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The decrease is primarily due to lower employee costs due to a reduction in general and administrative headcount, which occurred late in the first quarter of 2024, lower corporate costs related to insurance and information technology and lower spend for travel and business meetings.

Non-cash SG&A share-based compensation expense included within SG&A expenses was $7.5 million and $7.6 million for the three months ended March 31, 2024 and March 31, 2023, respectively.

R&D expenses, inclusive of share-based compensation expense, were $5.6 million and $13.2 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The primary drivers for the decrease were lower employee costs due to a reduction in headcount, which occurred late in the first quarter of 2024 and a decrease of clinical supply and distribution costs related to ceasing development of our AUR200 and AUR300 programs.

Non-cash R&D share-based compensation expense included within R&D expense was $(2.2) million and $1.6 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The non-cash R&D share-based compensation credit in the three months ended March 31, 2024 is due to the reversals of expense for forfeitures related to a reduction in headcount.

Restructuring expenses were approximately $6.7 million and nil for the three months ended March 31, 2024 and March 31, 2023, respectively. Restructuring expenses included employee severance, one-time benefit payments and contract termination expenses. The company recognized the majority of the planned restructuring costs in the first quarter of 2024.

Other (income) expense, net was $(4.1) million and $0.3 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The increase was primarily due the foreign exchange remeasurement of the monoplant lease liability, which commenced in June 2023 and is denominated in CHF.

Interest income was $4.5 million and $3.8 million for the three months ended March 31, 2024 and March 31, 2023, respectively. The increase is due to higher yields on our investments as a result of increased interest rates.

For the three months ended March 31, 2024, Aurinia recorded a net loss of $10.7 million or $(0.07) net loss per common share, as compared to a net loss of $26.2 million or $(0.18) net loss per common share for the three months ended March 31, 2023.

Financial Liquidity at March 31, 2024

As of March 31, 2024, Aurinia had cash, cash equivalents and restricted cash and investments of $320.1 million compared to $350.7 million at December 31, 2023. The decrease is primarily related to the continued investment in commercialization activities and post approval commitments of our approved drug, LUPKYNIS, monoplant payments, share repurchases and restructuring related payments, partially offset by an increase in cash receipts from sales of LUPKYNIS and payments from Otsuka.

Cash used in operations and non-GAAP free cash flow used were $18.6 million for the three months ended March 31, 2024 compared to cash used in operations of $31.7 million and non-GAAP free cash flow used of $32.0 million for the three months ended March 31, 2023.

Free cash flow is a non-GAAP financial measure calculated by subtracting purchases of property and equipment from net cash provided by or used in operating activities. Free cash flow reflects a view of our liquidity that, when viewed with our GAAP results, provides a more complete understanding of factors and trends affecting our cash flows. We believe it is a more conservative measure of cash flow since capital expenditures are necessary for ongoing operations. Free cash flow has limitations due to the fact that it does not represent the residual cash flow available for discretionary expenditures. For example, free cash flow does not incorporate the principal portion of payments made or expected to be made on finance lease obligations. Therefore, we believe it is important to view free cash flow as a complement to our entire consolidated statements of cash flows.

A reconciliation of free cash flow to its most directly comparable GAAP measure, net cash provided by or used in operating activities, is set out in the Condensed Consolidated Statement of Cash Flows included at the end of this press release.

Share Repurchase Program

As previously announced, Aurinia’s Board of Directors approved a share repurchase program of up to $150 million common shares of the Company. Canadian securities regulators also granted exemptive relief for the Company’s share repurchase program, authorizing the Company to purchase up to 15 percent of its issued and outstanding shares in any 12-month period for up to 36 months. Through April 30th, Aurinia has repurchased 3.4 million shares for approximately $18.4 million at an average cost of $5.37. The Company expects to fund its future discretionary share repurchases from cash flows from operations and cash currently on hand.

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, 2024 in the Company’s Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, including risk factors disclosed therein, which will be accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedarplus.ca 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, 2024 financial results today, Thursday, May 2, 2024 at 8:30 a.m. ET. The link to the audio webcast is available here or on Aurinia’s corporate website at www.auriniapharma.com under “News/Events” through the Investors section. To join the conference call, please dial +1 (877) 407-9170 / +1 201-493-6756 (Toll-free U.S. & Canada). A replay of the webcast will be available on Aurinia’s website.

About Lupus Nephritis

Lupus Nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. LN affects approximately 120,000 people in the U.S. and disproportionately affects women and people of color. People living with LN have high unmet needs and often face significant barriers to optimal care. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Medical guidelines recommend that all SLE patients receive routine LN screenings at every visit. Guidelines also note that delaying LN diagnosis has profound prognostic repercussions. Yet, research shows that approximately 50% of SLE patients are not screened for LN and 77% of people with LN go untreated. Aurinia is committed to improving health outcomes for people living with LN by educating patients and providers on the critical need for routine screening and transformative therapies that can help improve health outcomes.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy dedicated to the treatment of adult patients with active lupus nephritis. The Company’s head office is in Edmonton, Alberta, with its U.S. commercial office in Rockville, Maryland. The Company focuses its development efforts globally.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia’s expectations to be free cash flow positive (excluding share repurchases) in the second quarter of 2024; Aurinia’s estimates as to annual net product revenue from sales of LUPKYNIS in the range of $200 to $220 million in 2024; Aurinia’s expectations to recognize $50 to $55 million in annual cost savings, with 75% of those savings recognized in 2024, excluding a one-time restructuring charge of approximately $7 million incurred in the first quarter; Aurinia’s expectations that its total annualized operating expenses on a go-forward basis will be in the range of $185 to $195 million, with cash-based operating expenses of approximately $155 to $165 million; and Aurinia’s estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who have developed LN at time of SLE diagnosis. It is possible that such results or conclusions may change. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; the number, and timing of receipt, of PSFs and their rate of conversion into patients on therapy; assumptions relating to pricing for LUPKYNIS and patient persistency on the product; that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia’s assumptions relating to the capital required to fund operations; the assumption that Aurinia’s current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia’s cash for operations; assumptions related to timing of interactions with regulatory bodies; and that Aurinia’s third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia’s actual future financial and operational results may differ from its expectations; difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the widespread health concerns on Aurinia’s business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia’s clinical studies and from third party studies and reports may not be accurate; Aurinia’s third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; regulatory bodies may not grant approvals on conditions acceptable to Aurinia and its business partners, or at all; and Aurinia’s assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia’s control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com.

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

(unaudited)

 

March 31, 2024

 

December 31, 2023

 

 

 

 

 

ASSETS

 

 

 

 

Current assets

 

 

 

 

Cash, cash equivalents and restricted cash

 

$

64,459

 

 

$

48,875

 

Short-term investments

 

 

255,453

 

 

 

301,614

 

Accounts receivable, net

 

 

28,909

 

 

 

24,089

 

Inventories, net

 

 

39,761

 

 

 

39,705

 

Prepaid expenses

 

 

7,646

 

 

 

9,486

 

Other current assets

 

 

1,995

 

 

 

1,031

 

Total current assets

 

 

398,223

 

 

 

424,800

 

 

 

 

 

 

Non-current assets

 

 

 

 

Long-term investments

 

 

199

 

 

 

201

 

Other non-current assets

 

 

1,502

 

 

 

1,517

 

Property and equipment, net

 

 

3,198

 

 

 

3,354

 

Acquired intellectual property and other intangible assets, net

 

 

4,760

 

 

 

4,977

 

Finance right-of-use asset, net

 

 

104,358

 

 

 

108,715

 

Operating right-of-use assets, net

 

 

4,394

 

 

 

4,498

 

Total assets

 

$

516,634

 

 

$

548,062

 

 

 

 

 

 

LIABILITIES

 

 

 

 

Current liabilities

 

 

 

 

Accounts payable and accrued liabilities

 

 

50,270

 

 

 

54,389

 

Deferred revenue

 

 

4,909

 

 

 

4,813

 

Other current liabilities

 

 

1,150

 

 

 

2,388

 

Finance lease liability

 

 

13,724

 

 

 

14,609

 

Operating lease liabilities

 

 

999

 

 

 

989

 

Total current liabilities

 

 

71,052

 

 

 

77,188

 

 

 

 

 

 

Non-current liabilities

 

 

 

 

Finance lease liability

 

 

67,475

 

 

 

75,479

 

Operating lease liabilities

 

 

6,339

 

 

 

6,530

 

Deferred compensation and other non-current liabilities

 

 

12,292

 

 

 

10,911

 

Total liabilities

 

 

157,158

 

 

 

170,108

 

SHAREHOLDER’S EQUITY

 

 

 

 

Common shares - no par value, unlimited shares authorized, 143,690 and 143,833 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively

 

 

1,207,982

 

 

 

1,200,218

 

Additional paid-in capital

 

 

105,419

 

 

 

120,788

 

Accumulated other comprehensive loss

 

 

(854

)

 

 

(730

)

Accumulated deficit

 

 

(953,071

)

 

 

(942,322

)

Total shareholders' equity

 

 

359,476

 

 

 

377,954

 

Total liabilities and shareholders' equity

 

$

516,634

 

 

$

548,062

 

 

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

 

 

Three months ended

 

 

March 31,

 

 

2024

 

2023

 

(unaudited)

Revenue

 

 

 

 

Product revenue, net

 

$

48,073

 

 

$

34,337

 

License, collaboration and royalty revenue

 

 

2,230

 

 

 

72

 

Total revenue, net

 

 

50,303

 

 

 

34,409

 

Operating expenses

 

 

 

 

Cost of sales

 

 

7,752

 

 

 

421

 

Selling, general and administrative

 

 

47,695

 

 

 

50,124

 

Research and development

 

 

5,551

 

 

 

13,158

 

Restructuring expenses

 

 

6,683

 

 

 

—

 

Other (income) expense, net

 

 

(4,125

)

 

 

290

 

Total cost of sales and operating expenses

 

 

63,556

 

 

 

63,993

 

Loss from operations

 

 

(13,253

)

 

 

(29,584

)

Interest expense

 

 

(1,283

)

 

 

—

 

Interest income

 

 

4,526

 

 

 

3,814

 

Net loss before income taxes

 

 

(10,010

)

 

 

(25,770

)

Income tax expense

 

 

739

 

 

 

436

 

Net loss

 

$

(10,749

)

 

$

(26,206

)

Basic and diluted loss per share

 

$

(0.07

)

 

$

(0.18

)

Weighted-average common shares outstanding used in computation of basic and diluted loss per share

 

 

144,013

 

 

 

142,641

 

 

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

 

Three Months Ended March 31,

 

 

2024

 

2023

(in thousands)

 

(unaudited)

Cash flows used in operating activities:

 

 

 

 

Net loss

 

$

(10,749

)

 

$

(26,206

)

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

Depreciation and amortization

 

 

4,847

 

 

 

717

 

Net amortization of premiums and discounts on short-term investments

 

 

(3,206

)

 

 

(2,611

)

Share-based compensation expense

 

 

5,737

 

 

 

9,467

 

Foreign exchange on finance lease liability

 

 

(6,025

)

 

 

—

 

Other, net

 

 

1,559

 

 

 

217

 

Net changes in operating assets and liabilities

 

 

 

 

Accounts receivable, net

 

 

(4,820

)

 

 

(5,559

)

Inventories, net

 

 

(56

)

 

 

(6,993

)

Prepaid expenses and other current assets

 

 

873

 

 

 

3,588

 

Non-current operating assets

 

 

17

 

 

 

(17

)

Accounts payable, accrued and other liabilities

 

 

(6,594

)

 

 

(4,117

)

Operating lease liabilities

 

 

(181

)

 

 

(156

)

Net cash used in operating activities

 

 

(18,598

)

 

 

(31,670

)

Cash flows used in investing activities:

 

 

 

 

Purchase of investments

 

 

(121,260

)

 

 

(142,397

)

Proceeds from investments

 

 

170,505

 

 

 

167,766

 

Purchase of property and equipment

 

 

—

 

 

 

(347

)

Capitalized patent costs

 

 

(12

)

 

 

(162

)

Net cash provided by investing activities

 

 

49,233

 

 

 

24,860

 

Cash flows from financing activities

 

 

 

 

Repurchase of common shares, net of transaction costs

 

 

(12,301

)

 

 

—

 

Finance lease payments

 

 

(2,778

)

 

 

—

 

Proceeds from exercise of stock options

 

 

28

 

 

 

1,639

 

Cash (used in) provided by financing activities

 

 

(15,051

)

 

 

1,639

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

15,584

 

 

 

(5,171

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

48,875

 

 

 

94,172

 

Cash, cash equivalents and restricted cash, end of period

 

$

64,459

 

 

$

89,001

 

 

 

 

 

 

Reconciliation of free cash flow(1)

 

 

 

 

Net cash used in operating activities

 

$

(18,598

)

 

$

(31,670

)

Purchases of property and equipment

 

 

—

 

 

 

(347

)

Free cash flow

 

$

(18,598

)

 

$

(32,017

)

(1) Free cash flow is a non-GAAP financial measure and is calculated as net cash provided by or used in operating activities reduced by purchases of property and equipment.

 

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Media and Investor Inquiries: Andrea Christopher Corporate Communications and Investor Relations, Aurinia achristopher@auriniapharma.com ir@auriniapharma.com