May 2, 2024 - AUPH

Aurinia's Summer Slump: Is Seasonality Masking a Deeper Problem?

Aurinia Pharmaceuticals just reported a stellar first quarter in 2024, defying naysayers and exceeding expectations. Revenue surged, cash flow positivity is on the horizon, and the FDA even granted a long-awaited label update for LUPKYNIS, their flagship treatment for lupus nephritis. On the surface, everything seems rosy. But lurking beneath this triumphant narrative lies a subtle trend, a pattern so inconspicuous it might have slipped past the keenest Wall Street eyes. Aurinia, it seems, experiences a peculiar summer slump.

While the company confidently projects continued growth and reaffirms its 2024 revenue guidance, a closer examination of past performance reveals a recurring dip in key metrics during the summer months. This summer slowdown, while acknowledged by Aurinia's CEO, Peter Greenleaf, is brushed off as a mere seasonal fluctuation, a temporary blip on an otherwise upward trajectory.

But is it truly just seasonality? Or could this recurring dip be a symptom of a deeper underlying issue, a challenge Aurinia hasn't fully addressed? The answer might lie in the complex interplay of patient behavior, physician practice, and the inherent nature of lupus nephritis itself.

Aurinia's commercial success hinges on several factors, most notably patient start forms (PSFs), a metric tracking new patients initiating therapy. In the first quarter of 2024, PSFs, coupled with restarts (patients returning to therapy) and hospital fills, displayed robust growth. Aurinia added 596 new patients in Q1 2024 compared to 466 PSFs in Q1 2023, a 28% increase. However, April 2024 saw a slight dip in PSFs compared to the average monthly figures for Q1, a trend mirroring previous years.

A deeper dive into past earnings transcripts reveals that Aurinia has consistently experienced a summer flattening or dip in performance for three consecutive years. In 2023, PSF growth slowed down in the second and third quarters compared to the first and fourth quarters. This pattern suggests a recurring trend that transcends simple seasonality, particularly when combined with the April 2024 dip in PSFs.

Potential Causes of the Summer Slump

So, what could be driving this summer slump? Several possibilities emerge:

1. Patient Behavior

Summer often brings vacations, changes in routine, and increased outdoor activities. These factors might lead to a temporary lapse in adherence to medication schedules, impacting persistency (the proportion of patients remaining on therapy) and ultimately affecting revenue.

2. Nature of Lupus Nephritis

The disease is known for its unpredictable flares, and summer, with its increased sun exposure, might trigger exacerbations, leading to temporary discontinuation of LUPKYNIS. While these patients might eventually restart therapy, the disruption in treatment continuity would still contribute to the summer slowdown.

3. Physician Practice

Perhaps the most intriguing and potentially concerning factor lies in physician practice. Lupus nephritis, despite being a chronic disease, is often treated episodically by physicians, focusing on managing flares rather than long-term disease control. This practice, while slowly changing with the updated EULAR and KDIGO guidelines, remains prevalent and could contribute significantly to the summer dip.

Physicians might be more inclined to discontinue therapy during summer, perceiving it as a period of relative stability for patients, a time to give them a "break" from medication. This episodic approach, while seemingly well-intentioned, contradicts the latest treatment guidelines emphasizing continuous therapy for three to five years following complete renal response.

Aurinia's Response and the Path Forward

Aurinia is actively addressing this issue with their "Know the Signs" campaign, aimed at educating rheumatologists about the chronic nature of lupus nephritis and encouraging more aggressive screening and treatment. While this initiative is commendable, its effectiveness in shifting entrenched physician practice remains to be seen.

The coming months will be crucial for Aurinia. They are not just navigating a seasonal dip but facing a critical juncture, a test of their commercial strategy and their ability to reshape physician practice in a deeply entrenched therapeutic area. The summer of 2024 holds the answer – will it be a slump or a surge? The stakes are high, and Wall Street is watching.

Patient Start Forms (PSFs) and Other Growth Indicators

To understand Aurinia's performance, it's essential to track various commercial metrics, as highlighted in their earnings calls:

MetricQ1 2023Q1 2024Change
Patient Start Forms (PSFs)46659628% increase
Patients on Therapy (as of March 31)1,7312,17826% increase
Persistency (Patients remaining on therapy at 12 months)51%56%5% increase

Hypothetical Quarterly Revenue Projection

The following chart depicts a potential scenario for Aurinia's quarterly revenue, considering their guidance and historical summer trends.

Highlights

"Financial Health: Aurinia expects to be cash flow positive, excluding share repurchases, in Q2 2024, ahead of prior projections."
"Label Update: The FDA approved a label update for LUPKYNIS, removing language limiting the safety and efficacy assessment to one year and incorporating long-term data from the AURORA 2 extension study."
"Global Expansion: Aurinia is working towards regulatory approval for LUPKYNIS in Japan, with a decision expected in the second half of 2024."
"Fun Fact: Lupus affects an estimated 5 million people worldwide, with 90% of those affected being women."