Apellis Pharmaceuticals, Inc. announced a reduction to its internal staff and a restructuring of research initiatives for its long-term ophthalmic growth strategies.
Let’s start with this workforce cut.
The company revealed in an investor press release on August 29, 2023, that it will be reducing its workforce by 25% (equating to 250 employees), with the field-based commercial and medical employees to be minimally affected.
When is this taking effect?
Per Apellis, the cut is anticipated to be “substantially completed in the third quarter of 2023.”
To note, Q3 2023 concludes on October 31, 2023.
And the target goal?
The company expects these cuts to result in a cost savings of up to $300 million through 2024 (including +$70 million in expected net cost savings) as well as up to $230 million due to eliminating planned external expenses.
This is a significant cut…any positives here?
Yes. Apellis reported that, since the FDA approval of Syfovre (pegcetacoplan injection) 15 mg/0.1 mL in May 2023, the company has generated $85.7 million in U.S. net product revenue.
Since then, over 50,000 vials have been shipped across the country, with 26,000 vials distributed in Q3 2023 alone.
But wait … hasn’t there been some controversy with Syfovre?
Indeed, there has been:
In July 2023, the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee reported cases of occlusive and non-occlusive retinal vasculitis following a first injection of Syfore.
The company launched a review of the reports, providing an update that “no indication that drug product or manufacturing issues contributed to these events.”
As of August 23, 2023, eight cases of retinal vasculitis have been reported.
Gotcha. So what does Syfovre’s future look like?
The company is planning to continue its U.S. commercial rollout and also launch in ex-U.S.
Regulatory approval is also anticipated from the European Medicines Agency (EMA) by early 2024.
Any plans for its other pegcetacoplan medication?
The FDA-approved Empaveli (pegcetacoplan) is a non-ocular-focused medication indicated to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
The company intends to reduce expenses related to Empaveli; additionally, it has no plans to initiate any new clinical development programs for systemic pegcetacoplan.
Read more about additional development plans and upcoming clinical data here.
Now talk about these research initiatives.
Apellis plans to continue collaborating with biotech company Beacon Therapeutics on novel therapies for complement-driven diseases.
The company will also reprioritize its research to focus on opportunities for retina and central nervous system (CNS) diseases.
In contrast, it will deprioritize future research for other candidates:
- siRNA with systemic pegcetacoplan (existing and new indications)
- APL-1030 (neurology)
- APL-2006 (for GA and wet age-related macular degeneration [AMD])
Any words from the execs on these changes?
According to Apellis Co-Founder and CEO Cedric Francois, MD, PhD, the company’s actions are geared toward supporting its long-term success.
“These were difficult, but necessary, decisions,” Francois stated. “As a more focused organization, we believe these initiatives put Apellis in a stronger position to create value for shareholders and continue delivering on our mission for patients now and in the future.”