NASDAQ$PROK

ProKidney Corp · Q4 2022 earnings

Q4 2022 earnings · · Investor relations

Briefing

Reported financial results for the fourth quarter ended December 31, 2022.

ProKidney reported its Q4 2022 financial results, highlighting a cash position of $490.3 million, R&D expenses of $20.9 million, and G&A expenses of $9.3 million. The company's net loss before noncontrolling interest was $24.6 million.

  • Continued enrolling subjects in proact1, a Phase 3 randomized, blinded, sham-controlled study evaluating up to two doses of REACT given three months apart.
  • Received allowance of the proact1 study protocol from the UK Medicines and Healthcare Products Regulatory Agency, Health Canada and the Taiwan Food and Drug Administration.
  • Continued to progress toward the initiation of proact2, a Phase 3 randomized, blinded, sham-controlled study to assess the efficacy of up to two REACT injections.
  • Cash and cash equivalents as of December 31, 2022, were $490.3 million, compared to $20.6 million on December 31, 2021.

Headline financials

Total Revenue

$0.00

No prior period
EPS (adj)

-$0.11

No prior period
Capital Expenditures

$306K

No prior period
Free Cash Flow

-$16.1M

No prior period
Net Income

-$24.6M

No prior period
Operating Income

-$30.2M

No prior period
Cash & Equivalents

$490M

No prior period
Total Assets

$518M

No prior period
Stock-Based Comp

$8.94M

No prior period

Revenue & EPS history

ProKidney · Revenue · Quarterly

$0

Q4 2022
Beat estimate in 2 of 2 quarters(100%)
ActualEstimate

Forward guidance

The company expects to report topline data from proact1 by the end of 2024 which, if positive, could help support a future BLA submission for potential U.S. regulatory approval.

Tailwinds

  • Initial interim data from proact1 expected at the end of 2024.
  • Balance sheet, strengthened by the more than $500 million in net proceeds from PIPE financing in July 2022, will be sufficient to fund operations through 2024.
  • Regular interactions with the physician community at key medical congresses, aimed at broadening awareness of REACT among physicians.
  • REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation.
  • Received favorable scientific advice from the European Medicines Agency on the adequacy of Phase 3 development program.

Headwinds

  • The risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry.
  • The inability of the Company to raise financing in the future.
  • The inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product.
  • The inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases.
  • Uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities.

Historical earnings impact

How earnings announcements have historically affected this stock's price.

Avg. return before/after earnings

Based on 15 quarterly earnings reports · overlaid with Q4 2022

Historical avgQ4 2022

-2.4%

Avg return

Earnings day

-3.0%

Avg return

5 days after

+2.6%

Avg return

30 days after

25%

4 / 16 earnings

Positive

+18.0%

Q1 2024

Best reaction

-13.1%

Q3 2023

Worst reaction

Earnings price reactions
QuarterReport dateReaction (Day 0)+5 days+30 days
Q1 2026-2.3%-1.2%-4.7%
Q4 2025-4.0%-8.9%+2.3%
Q3 2025-8.8%-16.6%-24.9%
Q2 2025-0.9%+4.7%+32.2%
Q1 2025-6.0%-9.3%-1.4%
Q4 2024-6.8%-7.7%-23.9%
Q3 2024-3.7%-21.2%-12.6%
Q2 2024-0.5%+9.1%+11.5%
Q1 2024+18.0%+50.2%+22.2%
Q4 2023-4.1%+8.9%+39.7%
Q3 2023-13.1%-24.4%+20.0%
Q2 2023+0.4%-14.5%-37.5%
Q1 2023+1.2%+8.1%+34.0%
Q4 2022-9.8%-12.9%-24.6%
Q3 2022-4.7%-14.8%-23.6%
Q2 2022+7.3%+2.7%+32.6%

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