EarningsQ2 2026 Earnings Report
SPHDF Q2 2026 EPS Results
Actual EPS-$0.11
Consensus EPS$0.20
Beat/MissMissed by -$0.31
One Year Ago EPS-$0.44
SPHDF Q2 2026 Revenue Results
Actual Revenue$57.78M
Expected Revenue$35.03M
Beat/MissBeat by +$22.75M
YoY Revenue Growth+101.27%
Earnings Announcement Details
QuarterQ2 2026
Date09/30/2026
TimeBefore Open
Conference CallWednesday, September 30, 2026
SPHDF Upcoming Earnings
Santhera Pharmaceuticals Holding's next earnings date is estimated for April 29, 2027, based on past reporting schedules.
Q2 2026 Earnings Call Audio
SPHDF Q2 2026 Earnings Call
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Q2 2026 Earnings Slide Deck
Q2 2026 Earnings Call Summary
Earnings Call Sentiment|Positive
The call was strongly positive, with substantial revenue growth, improving operating performance, expanding market access, strong commercial uptake and supportive long-term efficacy and safety data. The main challenges were the unexpected 8.5% German pricing discount, an anticipated cash decline in the first half of 2027, the delayed French launch, ongoing reimbursement work in several markets and uncertainty around future partnering and additional-asset financing. Overall, the breadth and strength of the reported commercial and clinical progress significantly outweighed the disclosed challenges.Company Guidance
Strong First-Half Revenue Growth
First-half revenue grew by over 100% to CHF 48.3 million, driven by strong AGAMREE sales and recognition of income components from the Nxera licensing agreement.
Product Sales and Royalty Income Increased
Product sales from direct and distributor markets increased 48% versus the prior-year period. Santhera received CHF 29.1 million in royalties and milestones, primarily from the $30 million Nxera cash upfront payment and royalty payments from Catalyst and Sperogenix.
Operating Loss Narrowed and Costs Were Controlled
Operating expenses decreased 8.4% to CHF 25 million, while the operating loss narrowed to CHF 6.6 million from CHF 35.4 million in the prior year. The reduction in expenses was primarily attributed to lower development costs as postmarketing studies were completed.
Healthy Cash Balance and No Additional Funding Required
Cash stood at CHF 41.8 million as of June 30, 2026. Management said cash is expected to be broadly stable through year-end and that the company will not require additional funding despite a projected cash-flow change in 2027.
European Commercial Expansion
AGAMREE is commercially launched in four of the five major EU markets—Germany, the U.K., Spain and Italy—and has also launched in Austria and Luxembourg. Pricing and reimbursement have been secured in Spain and Italy, and reimbursement in Poland was secured effective October 1, 2026.
Strong German Commercial Momentum
German AGAMREE volumes increased 50% in the first half of 2026 versus the first half of 2025. AGAMREE reached a 40% share of steroid-using DMD patients in Germany, with uptake coming from newly diagnosed patients, switching patients and increasingly older DMD patients.
U.K. and Austrian Market Share Progress
U.K. orders increased by more than 40% in the second quarter of 2026 versus the first quarter, supported by systematic adoption across specialty DMD centers, updated treatment guidelines and home-delivery programs. AGAMREE reached 50% of steroid use among DMD patients in Austria.
Expanded Distributor Footprint
Santhera expanded its distributor agreement with Biomedica to include Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan. The added Central Asia and Caucasus region represents more than 2,000 additional DMD patients. Genesis now covers 13 Central and Eastern European countries and secured marketing authorization for Serbia.
Strategic Nxera Licensing Agreement
The Nxera agreement covers Japan, South Korea, Australia and New Zealand and has a total deal value of up to $215 million plus royalties, including $30 million in cash and $10 million in equity investment in Santhera. Nxera is targeting a Japanese marketing authorization filing in the second half of 2027 and is on track to submit in South Korea after receiving ODD and GIFT designations.
Potential AGAMREE Indication Expansion
Beyond DMD, Nxera is studying potential additional indications including Fukuyama congenital muscular dystrophy, pediatric nephrotic syndrome and juvenile dermatomyositis. Santhera expects to collaborate on this expansion and would benefit from royalties if the indications become commercial.
U.S. Sales Momentum and Catalyst Acquisition
Catalyst reported AGAMREE net product sales of $36.7 million in the first quarter of 2026, up from $22 million in the first quarter of 2025. Catalyst had reported that 90% of DMD centers of excellence were using AGAMREE, and Angelini Pharma completed its $4.1 billion acquisition of Catalyst on July 16, 2026. Management expects continuity and potentially acceleration of commercial efforts.
Positive Long-Term Efficacy and Safety Data
Real-world data covering a median of 5 years and up to 8 years of vamorolone treatment showed durable efficacy equivalent to current corticosteroid standards of care, including time to loss of ambulation. Patients maintained approximately 80% of their starting dose over 8 years, children maintained a normal growth trajectory, and no new safety signals were observed.
Meaningful Reduction in Vertical Fractures
Vertical fractures occurred in 8.1% of patients treated with vamorolone versus 41.9% of patients treated with deflazacort. Management also reported 80% fewer vertical fractures, improvements in overall eye health and an approximately 12-centimeter height difference after 8 years compared with deflazacort and prednisone.
Evidence of Benefit in Older Non-Ambulatory Patients
In an independent study of approximately 25 patients at one center, all 8 patients treated with vamorolone showed stabilization or improvement in muscle function. The population consisted of wheelchair-bound patients reliant on upper-limb function, including patients who switched to or restarted vamorolone.
Expanded EU Label and Positive Regulatory Progress
The CHMP adopted a positive opinion recommending expansion of the AGAMREE indication in the EU to patients from 2 years of age, compared with the prior age threshold of 4 years. Swissmedic approved AGAMREE in Switzerland in January 2026, and Luxembourg agreed pricing and reimbursement in August 2026.
China Patient Uptake
Following a commercial launch in China approximately one year earlier without reimbursement, close to 1,000 patients had been treated with AGAMREE. Sperogenix continues to pursue national reimbursement drug-listing approval.
Updated Financial Guidance and Long-Term Targets
2026 guidance remains unchanged at CHF 80 million to CHF 90 million of revenue, with product sales expected to grow by more than 50%, royalty income expected to increase year-on-year and operating expenses expected to be CHF 50 million to CHF 55 million. The company targets CHF 140 million of 2028 revenue and CHF 250 million of revenue by 2030, including direct markets, distributor markets and royalties.
Underlying Operational Cash Position
Management stated that, excluding sales milestones and financing costs, the business is operationally cash positive. The company also said that the CHF 80 million to CHF 90 million 2026 revenue guidance is based on the underlying business and excludes potential additional sales milestones.
Pipeline and Portfolio-Building Priorities
Santhera plans to continue pursuing a Latin America distribution agreement, additional indications through partners and the in-licensing of a synergistic late-stage rare or orphan asset that is commercially ready or close to market. Management said its CHF 50 million to CHF 55 million operating expense base can support one or two additional assets.
SPHDF Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed