3/17/2022

speaker
Jen Hopkins
Head of Investor Relations and Corporate Communications

Good morning and good afternoon, everyone. Thank you for joining us today. My name is Jen Hopkins, Head of Investor Relations and Corporate Communications at Silence. Joining me today on the call are Craig Tooman, our President and Chief Executive Officer, who will provide an update on the business, Ronna Helms, our Chief Financial Officer, who will review our financials, and Dr. Giles Campion, our Head of R&D, who will provide an update on our clinical programs before opening the call to your questions. For those of you participating via conference call, the accompanying slides can be accessed by going to the investor section of our corporate website at www.silence-therapeutics.com. Turning to slide two, I'd like to remind you that during today's call, management will make projections or other forward-looking statements regarding anticipated future events or the future financial performance of the company, including clinical development timing and objectives, the therapeutic potential of our product candidates, are operational plans and strategies, anticipated milestone payments, anticipated operating and capital expenditures, business prospects, and projected cash runway. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent annual report on file with the FCC. In addition, any forward-looking statements represent our views only as of the date of this recording. It should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. With that, I'd like to turn the call over to Craig. Craig?

speaker
Craig Tooman
President and Chief Executive Officer

Thank you, Jem, and welcome, everyone. Thank you for making the time to join us today. Turning to slide three, 2021 was a remarkable year for silence, highlighted by the first successful clinical data from our proprietary mRNAI gold platform and the emergence of the company as a globally recognized peer trading on NASDAQ with top-tier investors. Silence is well positioned for long-term growth in the very dynamic SIRNA space, and we are very excited about our future prospects. Regarding our pipeline, the results from the SLN124 Healthy Volunteer Study last May demonstrated proof of mechanism and showed our ability to effectively translate preclinical results into the clinic. With this backdrop, we made excellent progress during the year, advancing both our wholly owned and partnered programs targeting genetic diseases in the liver. We completed enrollment in the SLN360 Phase 1 study in healthy adults with high LP little a, setting us up for the positive data readout we just reported this quarter. We also started dosing patients in the SLN124 Phase 1 program. Giles will provide an update on both programs later in the call. On the partnering side, we secured a new collaboration with Hanso Pharma that added three new targets to our pipeline. We also continued to advance our collaborations with AstraZeneca and Malincron. Collectively, these collaborations brought in a total of $58 million in non-dilutive cash in 2021. This really demonstrates the value of our hybrid business model to expand our pipeline and provide a steady stream of non-dilutive capital to support our internal R&D efforts. Earlier in the year, we completed a $45 million private placement that laid the groundwork for expanding our global shareholder base. We built on this in the second half of the year with our successful AMD listing in November, a move we made to support increasing interest from new investors. Along with our exclusive NASDAQ listing, we welcome several new U.S. healthcare funds as key shareholders to Silence. Turning to slide four, we've entered 2022 with incredible momentum. As you probably know, we just reported very encouraging clinical data for SLM 360 last month. That's the second positive clinical data set from our gold platform. This is a real tribute to Giles and the R&D team who have strategized and led this effort. And I know he's looking forward to telling you more about this. SLN 360 is a priority asset for us where we see substantial opportunity to build value. We're looking forward to the full study results being presented in a late breaker at ACC on April 3rd. Beyond the ACC presentation, We expect more durability data in the third quarter and remain on track to start the phase two ASCVD study later this year, pending regulatory feedback. We expect to capitalize on the growing appreciation for SLN360 and are engaged in global partnership discussions to ensure we maximize this high value program going forward. Moving to SLN124, we have now fully enrolled the thalassemia study and remain on track for top line data in the third quarter. Given enrollment challenges in the MDS study and our commitment to prioritize investment in areas where we believe we can create the most value, we've decided to discontinue the MDS cohorts and focus on thalassemia and polycythemia vera, or PV. We are very pleased that the FDA recently granted SLN124, orphan drug designation, for PV last month, adding to the other designations we already have. And we expect to start a phase one study later this year. On the partnering side, we're on track to move the SLN 501 program with Mallinckrodt for complement mediated diseases into the clinic in the first half of this year. We are very pleased that the pipeline continues to progress very well, both internally and with our partners. Before I turn the call over to Rhonda for an update on our financials, I just want to highlight an important point. What is particularly attractive about our gold platform and the GalNac siRNA approach is its well-established modality with a track record of clinical success. In fact, historically, GalNac siRNA programs have had a much higher success rate in moving from phase one to phase three compared to the pharma industry average. That's why we're so excited about our advancing clinical pipeline. Going forward, we will prioritize investment in our clinical pipeline in the areas where we believe we can generate the most value while always being careful stewards of our shareholders' capital. With that, I'd like to turn the call over to Rhonda for an update on our financial performance. Rhonda?

speaker
Ronna Helms
Chief Financial Officer

Thank you, Craig. Turning to slide seven, for the period ending December 31, 2021, the company recorded 12.4 million pounds in revenues. versus 5.5 million pounds in 2020. The increase of 6.9 million pounds was primarily driven by the advancement of targets in our Mallinckrodt and AstraZeneca collaboration, which together delivered 11.4 million pounds in 2021. We also recorded approximately 392,000 in royalty revenue during 2021. As a reminder, We record revenue from our collaborations based on a percentage of contract completion. Therefore, as our current collaboration programs progress, such as SLN 501 did in 2021, and additional programs are initiated, such as those programs associated with our HONSO agreement, which was executed in October of 2021, our revenues are also estimated to increase. The expenses related to our partner programs, including the portion of our employees' time dedicated to these programs, are recorded as cost of sales as they are attributed to the revenues. As expected, R&D costs rose in 2021 to 30.8 million pounds versus 20.2 million pounds in 2020. This increase is primarily due to advancing our proprietary SLN360 and SLN124 programs and the increase in headcount costs due to the addition of R&D expertise to support our innovative pipeline. General and administrative costs were 20 million pounds in 2021 versus 14 million pounds in 2020. The increase was primarily driven by requirements of being a public company, dual listed on both the NASDAQ and AIM for most of 2021, and support for the growth of our R&D programs. These costs include an increase in non-cash share-based expenses related to the granting of employee share options and further enhancement of our support functions, including personnel. As Craig mentioned earlier, in late November, we delisted from the AIM and are now solely listed on the NASDAQ. The company's net loss for the full year of 2021 was 39.4 million pounds, versus 32.5 million pounds in 2020. The increase of 13.2 million pounds is related primarily from the R&D and G&A expenses, but those are partially offset by the increase in gross profit from our collaboration. Turning to slide eight, the company's cash and cash equivalents were 73.5 million pounds or approximately $99 million at the end of December 2021. As Craig mentioned, during 2021, we received 44.4 million pounds or $58.4 million from our collaboration partners. This includes proceeds of $40 million or 30.8 million pounds from AstraZeneca in May and a $16 million upfront payment from HONSO in December, which net of taxes was approximately 10.7 million pounds. We also received proceeds of $45 million, or approximately 33 million pounds, from our oversubscribed private placement of our ADSs in February of 2021. We are not providing any specific guidance on spending today, but we are committed to responsibly investing in initiatives that will advance our pipeline and in the valuable programs that offer the potential to address important diseases that impact many individuals worldwide. We estimate that our current cash balance of 73.5 million pounds will last until early 2023. We will continue to leverage our hybrid business model and evaluate new additional non-diluted collaboration agreements. With that, I will turn the call over to Giles for clinical updates. Giles?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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