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scPharmaceuticals Inc. (SCPH)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 delivered continued commercial traction: net FUROSCIX revenue rose to $10.0M (+24% q/q; +164% y/y) on 10,800 doses filled and rising doses per script (6.8), but EPS was a larger loss at $(0.75) due to one-time financing-related charges ($0.47/share) .
  • Commercial KPIs improved: cumulative prescribers reached ~3,100 (up ~14% q/q), fill rate improved to 53% (from 48% in Q2), and IDN/hospital direct purchasing expanded to 14 YTD; a 5.5% price increase at September-end should support revenue into Q4 .
  • Near-term catalysts are robust: Class IV label expansion (approved in August), CKD sNDA PDUFA set for March 6, 2025, and an autoinjector sNDA targeted for January 2025; management also flagged seasonal strength in Q4 and early Q4 momentum with fill rates at 54–55% thus far .
  • Gross-to-net (GTN) discount stepped up to 15.7% in Q3 (vs. 8% in Q2) largely from coverage gap dynamics; management expects GTN to remain 10–15% for the balance of 2024 and to increase up to ~35% by end of 2025 as Medicare Part D redesign takes effect (with lower patient co-pays expected to improve conversion) .

What Went Well and What Went Wrong

  • What Went Well
    • Strong top-line growth: Q3 net product revenue rose to $10.0M (+24% q/q; +164% y/y) as doses filled and average doses per Rx increased to ~10,800 and 6.8, respectively .
    • Commercial execution: cumulative prescribers reached ~3,100; fill rate improved to 53% (vs. 48% in Q2); IDN/hospital direct purchases reached 14 YTD; management cited sales force expansion and Class IV label as tailwinds .
    • Strategic catalysts on track: CKD PDUFA (Mar 6, 2025), autoinjector sNDA targeted for Jan 2025; management highlighted expected manufacturing cost benefits and strong receptivity from nephrology .
  • What Went Wrong
    • Margin headwinds: GTN rose to 15.7% (above prior 10–15% range) driven by coverage-gap rebates; management cited impact on revenue recognition and patient abandonment when co-pays are high .
    • Larger net loss: Q3 net loss widened to $(35.1)M and EPS to $(0.75), driven by one-time charges from extinguishment of debt and new instruments (~$0.47/share burden) .
    • Timing adjustments: autoinjector sNDA timeline shifted to January 2025 (from prior target “by end of 2024”) .

Financial Results

Overall P&L and margin progression (USD millions unless noted)

MetricQ1 2024Q2 2024Q3 2024
Revenues ($M)$6.102 $8.054 $10.026
Loss from Operations (EBIT) ($M)$(15.856) $(14.431) $(18.146)
Net Loss ($M)$(14.108) $(17.090) $(35.105)
Diluted EPS ($)$(0.36) $(0.44) $(0.75)
Net Income Margin %-231% (calc) -212% (calc) -350% (calc)
EBIT Margin %-260% (calc) -179% (calc) -181% (calc)
Gross-to-Net (GTN) %19% 8% 15.7%

Q3 vs prior year and prior quarter

MetricQ3 2023Q3 2024YoY ChangeQ2 2024Q3 2024QoQ Change
Revenue ($M)$3.796 $10.026 +164% (calc) $8.054 $10.026 +24% (calc)
Cost of Product Rev. ($M)$1.079 $3.311 +207% (calc) $2.300 $3.311 +44% (calc)
SG&A ($M)$14.135 $21.320 +51% (calc) $17.508 $21.320 +22% (calc)
Net Loss ($M)$(15.634) $(35.105) -$19.5M (calc) $(17.090) $(35.105) -$18.0M (calc)
Diluted EPS ($)$(0.41) $(0.75) $(0.34) (calc) $(0.44) $(0.75) $(0.31) (calc)

Balance sheet context (period-end): cash & equivalents $91.5M (9/30/24); total shares outstanding 50,040,134 (9/30/24) . Term loan $51.099M and revenue purchase and sale liability $26.830M at 9/30/24 .

Segment breakdown: not applicable; FUROSCIX is the sole commercial product .

KPIs

KPIQ1 2024Q2 2024Q3 2024
Doses Filled8,074 ~9,300 ~10,800
Avg Doses per Rx6.1 6.3 6.8
Unique Prescribers (cumulative)2,184 2,713 ~3,100
Fill Rate (%)~46.5% (calc from written/filled) ~48% ~53%
IDN/Hospital Direct Purchases (YTD)——14
Price Increase——+5.5% at Sept-end

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GTN Discount2H2410–15% (Q2 commentary) 10–15% for balance of 2024 Maintained
GTN Discount2025 exitLonger-term 30–35% “appropriate” Up to ~35% by end of 2025 Timing clarified to 2025
Fill Rate (model)2025—~65% modeled for 2025 New disclosure
Autoinjector sNDAFilingTarget “by end of 2024” Target January 2025 Delayed
CKD sNDAPDUFAMarch 6, 2025 (announced in Q2) March 6, 2025 (reaffirmed) Maintained
Sales ForceQ4 2024Plan to reach ~90 territories by end Q3 Expansion completed late Sept; ~90 territories in Q4 Executed
Pricing2024—5.5% price increase at Sept-end New action

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2024)Current Period (Q3 2024)Trend
GTN/Medicare RedesignGTN 19% in Q1; expected to rise LT to 30–35%; Q2 GTN 8%; guided 10–15% for next 2 quarters; Medicare redesign expected to lift conversion GTN 15.7% in Q3; expect 10–15% rest of 2024; up to ~35% by end 2025; redesign to lower co-pays and boost fill GTN stepped up; 2025 tailwind reinforced
Sales Force & HubAdded territories planned; hub change underway; Q2 hub caused temporary fill headwind; fill improved to 60%+ for August ~90 territories in Q4; hub “continues to perform well”; fill rate 53% in Q3, 54–55% early Q4 Capacity expanded; operational throughput improving
Class IV LabelPDUFA in Aug; approval announced Aug 12 Early Class IV penetration (~10% of scripts) with larger script sizes (~8 doses) Early contribution; supports higher doses/Rx
CKD IndicationsNDA accepted; PDUFA Mar 6, 2025 Pre-launch prep; positive nephrology receptivity; PDUFA re-affirmed On track; expanding call points
AutoinjectorPositive topline PK/PD; target sNDA end-2024 sNDA targeted Jan 2025; expectation of majority conversion to autoinjector LT (90–95%) Slight timing slip; large LT COGS opportunity
IDN/Hospital SystemsGrowing interest; Kaiser protocol usage post-discharge; VA/Kaiser formulary efforts 14 direct-purchasing IDNs YTD; internal distribution momentum Institutional channel building
Seasonality“Holiday heart” strength in Q4 noted in Q1 call Q4 is biggest opportunity; pre-emptive scripts; early Q4 momentum Positive Q4 setup

Management Commentary

  • “The continued growth of FUROSCIX net revenue is encouraging…We anticipate the expansion of the sales force that we completed in late September to have a potentially meaningful impact on sales moving forward.” — John Tucker, CEO .
  • “We see [Q4] growth being driven by the sales force expansion, the indication expansion to include Class IV patients and continued growth in the IDN business.” — John Tucker, CEO .
  • “ScPharmaceuticals’ net loss for the third quarter of 2024 was $0.75 per share. The $0.75 per share was burdened by one-time charges of $0.47 per share.” — Rachael Nokes, CFO .
  • “For the balance of 2024, we anticipate the GTN to stay in the 10% to 15% range. And in 2025, we anticipate the GTN discount to increase up to 35% by the end of the year, driven by the Medicare Part D redesign.” — John Tucker, CEO .

Q&A Highlights

  • CKD dosing expectations: average doses per prescription expected to be “similar” to Class II/III heart failure, around 6–6.5 doses per script .
  • Autoinjector adoption: management modeled long-run 90–95% of utilization shifting to the autoinjector if approved (timing of adoption to be determined) .
  • Fill rate trends: Q3 fill rate ~53% vs. ~48% in Q2; early Q4 running ~54–55% as coverage-gap pressures ease .
  • Class IV contribution: ~10% of scripts currently, with larger average script size (~8 doses), expected to grow .
  • 2025 model: company projects 65% fill rate under Medicare redesign with copay smoothing ($166/month), supporting higher prescribing and conversion .

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 revenue and EPS was unavailable at the time of this analysis due to a data access limit. As a result, we cannot definitively assess beats/misses versus consensus for Q3 2024 from S&P Global. If you want, we can refresh and add consensus once access is restored.

Key Takeaways for Investors

  • FUROSCIX demand remains on an upward trajectory (revenue +24% q/q; doses filled +16% q/q; doses per Rx rising), aided by Class IV label and expanding IDN penetration—supportive of sustained top-line growth into Q4 and 2025 .
  • Q3 margin optics were pressured by coverage-gap dynamics (GTN 15.7% vs. 8% in Q2) and one-time financing charges; 2025 Medicare redesign should lower patient out-of-pocket and lift conversion/fill rates, even as GTN mechanically rises (net revenue impact expected to benefit from higher volumes) .
  • Sales force scale-up (~90 territories), a modernized hub, and seasonally strong Q4 create a favorable near-term setup (management cited early Q4 fill improvement, 54–55%) .
  • Pipeline/lifecycle catalysts are stacked: CKD PDUFA Mar 6, 2025; autoinjector sNDA in Jan 2025 with potential to lower COGS and capture majority of volume LT; both are stock-relevant events .
  • Pricing power signaled via a 5.5% price increase in late Sept; along with larger scripts in Class IV, this can amplify revenue per script in Q4–Q1 seasonally strong periods .
  • Balance sheet strengthened by Perceptive financings and equity raise in August (net addition of roughly $75M at close; access to additional $50M), funding runway through expected profitability per management commentary .
  • Watch list: execution on IDN rollouts, payer conversions under Part D redesign, autoinjector FDA timing/label, and CKD launch readiness in nephrology—each can accelerate adoption and narrative momentum .

Appendix: Source Documents

  • Q3 2024 8-K & Exhibit 99.1 press release: operating results, KPIs, balance sheet data .
  • Q3 2024 earnings call transcript: strategic commentary, GTN and fill rate guidance, Q&A details –.
  • Q2 2024 press release and call: sequential trend context, initial GTN guide, label/CKD updates – –.
  • Class IV label expansion press release (Aug 12, 2024): indication update .
  • Financing press releases (Aug 12, 2024): non-dilutive financings and equity raise –.