Renalytix plc(US:RNLX)2022-03-31 11:00Revenue and Growth - Revenue for Q2 FY2022 was $0.8 million, up from $0.4 million in Q2 FY2021, representing a 100% year-over-year increase[4] - Testing revenues for Q2 were $0.7 million, an increase from $0.5 million in Q1, with expectations for further growth as additional hospital systems come online in fiscal 2023[31] - Revenue for the three months ended December 31, 2021, was $845,000, a 111.25% increase compared to $400,000 for the same period in 2020[60] - The company recognized $1.1 million in revenue related to KidneyIntelX during the six months ended December 31, 2021, compared to $0.4 million in the same period of 2020[42] - The Company recognized $0.7 million and $1.1 million in testing services revenue for the three and six months ended December 31, 2021, respectively, compared to no revenue in the same periods of 2020[108] Operating Expenses - Operating expenses increased to $14.1 million in Q2 FY2022 from $8.8 million in the prior year, reflecting a 60% increase[4] - Total operating expenses for the three months ended December 31, 2021, were $14,135,000, up 61.5% from $8,756,000 in the same period of 2020[60] - General and administrative expenses were $10.1 million, up by $3.5 million from $6.6 million in the same period last year[7] - Research and development expenses rose to $4.1 million, an increase of $1.6 million from $2.5 million in Q2 FY2021[6] - Research and development expenses for the three months ended December 31, 2021, were $4,134,000, an increase from $2,462,000 in the same period of 2020[60] Net Loss and Financial Position - Net loss attributable to ordinary shareholders was $15.3 million for Q2 FY2022, compared to $8.9 million in Q2 FY2021[8] - Net loss for the six months ended December 31, 2021, was $25,428,000, compared to a net loss of $16,740,000 for the same period in 2020, indicating a worsening financial position[66] - The company reported a net loss per ordinary share of $0.21 for the three months ended December 31, 2021, compared to $0.12 for the same period in 2020[60] - The company’s comprehensive loss for the six months ended December 31, 2021, was $27,916,000, compared to $8,399,000 for the same period in 2020[60] - As of December 31, 2021, the company had an accumulated deficit of $113.0 million and cash and cash equivalents of $39.9 million, which are expected to fund operations for at least the next twelve months[70] Cash Flow and Assets - Cash and cash equivalents decreased to $39.9 million as of December 31, 2021, down from $65.2 million as of June 30, 2021, due to ongoing commercialization efforts[55] - Total assets decreased to $54.4 million as of December 31, 2021, from $78.6 million as of June 30, 2021[58] - Cash and cash equivalents at the end of the period were $39,928,000, down from $74,532,000 at the end of the same period in 2020[66] Partnerships and Contracts - 22 private insurance coverage contracts executed, including the first regional Blue Cross Blue Shield plans[5] - 31 state Medicaid programs contracted, with additional states expected to join this calendar year[5] - KidneyIntelX is now available at 16 Veterans Administration health centers, with more expected to be added this year[5] - The company has entered into a master service agreement with AstraZeneca for future services related to the KidneyIntelX platform[67] - The Company has a Master Care Coordination Services Agreement with DaVita Inc., with a monthly payment structure of $10.00 per covered patient for care coordination services and $3.50 for patient engagement services[125] Research and Development - Research and development expenses primarily related to the development of KidneyIntelX, with costs expensed as incurred[96] - The company incurred approximately $0.2 million and $0.4 million in research and development expenses under the ISMMS SRA for the three and six months ended December 31, 2021, respectively[129] - Research and development expenses related to the Icahn School of Medicine amounted to $1.5 million and $2.7 million for the three and six months ended December 31, 2021, compared to $0.3 million for both periods in 2020[147] Future Outlook and Funding - The company anticipates strengthening test volumes as it progresses through the fiscal year, supported by its partnership with Mount Sinai Health System[31] - The company plans to pursue collaborations with pharmaceutical companies, aiming to make 'Pharmaceutical Services Revenue' a core part of its business[67] - The company plans to seek additional funding through public or private equity offerings, debt financings, and strategic alliances[71] - The company is subject to risks typical of early-stage diagnostics companies, including the need for significant capital to fund operations and the development of new products[69] Shareholder Information - The weighted average ordinary shares outstanding for the three months ended December 31, 2021, were 72,285,941, compared to 72,029,634 for the same period in 2020[60] - As of December 31, 2021, the Company had 76,681,831 ordinary shares authorized on a fully diluted basis, with no cash dividends declared or paid since inception[135] - The weighted average fair value of options granted during the six months ended December 31, 2021 was $7.10 per share, compared to $4.31 per share in 2020[140] - As of December 31, 2021, there was $8.5 million in unrecognized compensation cost related to unvested options, expected to be recognized over a weighted average period of 1.98 years[141] Miscellaneous - The company has provided integrated advanced risk assessment services for over 2,600 patients with kidney disease and diabetes[23] - The company has not recorded any reserves for doubtful accounts as of December 31, 2021, indicating a positive outlook on collectability[84] - The Company recorded share-based compensation expense of $0.913 million for the three months ended December 31, 2021, compared to $0.502 million for the same period in 2020[139] - The company incurred related-party expenses of $0.1 million for both the three and six months ended December 31, 2021, consistent with the same amounts in 2020[146] - The company has evaluated subsequent events and determined there are no items requiring disclosure[154]