Nuwellis, Inc. current report, 26 June 2015

Business Context and Reporting Period

This Form 8-K is filed by Sunshine Heart, Inc. (not Nuwellis, Inc.) on June 26, 2015. The report details the funding of a milestone-based term loan under a previously disclosed agreement with Silicon Valley Bank.

Key Financial Metrics

  • Debt Financing: The Company borrowed an additional $2.0 million (Term B Loan) on June 26, 2015.
  • Commitment Fee: A fee of 1% of the Term B Loan ($20,000) was paid to the Bank.
  • Total Facility: The aggregate principal amount of the loan facility is up to $10.0 million, consisting of a $6.0 million initial term loan, the $2.0 million Term B Loan, and a potential $2.0 million Term C Loan.
  • Liquidity Requirement: The Company must complete an equity financing resulting in unencumbered net cash proceeds of at least $20.0 million by March 31, 2016.
  • Equity Issuance: Warrants previously issued to the Bank became exercisable for additional shares equal to 6% of the Term B Loan amount divided by the Funding Shares Warrant Price.

Material Changes

The primary material change is the achievement of the regulatory milestone required to access the Term B Loan. The U.S. Food and Drug Administration granted an interim analysis of the Company's "C-Pulse Heart Assist System" product in February 2015, triggering the availability of the $2.0 million funding which was executed on June 26, 2015.

Outlook, Risks, and Contingencies

  • Future Financing Obligation: The Company is contractually obligated to raise at least $20.0 million in equity by March 31, 2016, to maintain the loan terms.
  • Dilution Risk: The funding of the Term B Loan triggered the exercisability of additional warrants, potentially diluting existing shareholders.
  • Unregistered Securities: The warrants and underlying shares were issued under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D and are not registered with the SEC.
  • Remaining Milestone: An additional $2.0 million term loan remains available if the Company enrolls 100 patients in the "U.S. Counter HF" study by September 30, 2015.

Investor Verification Checklist

  • Verify the Company's progress toward the $20.0 million equity financing deadline of March 31, 2016.
  • Confirm the status of patient enrollment for the "U.S. Counter HF" study to determine eligibility for the remaining $2.0 million loan tranche.
  • Review the impact of the newly exercisable warrants on the Company's capital structure and potential dilution.
  • Check for any subsequent filings regarding the equity financing efforts required by the loan agreement.