On August 8, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the second quarter of 2023, and associated Company developments (Press release, Supernus, AUG 8, 2023, View Source [SID1234633992]).

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"Our growth products continue to deliver robust growth with Qelbree and GOCOVRI combined net product sales growing by 67% in the second quarter of 2023 compared to the same period last year," said Jack Khattar, President and CEO of Supernus. "In addition, despite the seasonally weak summer season in the ADHD market, Qelbree’s net product sales grew by 20% in the second quarter of 2023 compared to the first quarter of 2023 showing the resiliency of the brand and its growth potential. We remain well positioned to drive strong revenue growth in 2024 and beyond."

Qelbree Update

Total IQVIA prescriptions were 146,344 in the second quarter of 2023, an increase of 133% compared to the same period last year and 9% compared to the first quarter of 2023.
Increase in prescription size and improvement in gross to net resulting in 10% increase in average net price per prescription to $212 in the second quarter of 2023 compared to the first quarter.
Qelbree continues to expand its base of prescribers, with approximately 21,291 prescribers in the second quarter of 2023, up from 19,197 prescribers in the first quarter of 2023.
The salesforce expansion has been completed and the field sales team is fully trained, allowing the Company broader reach and increased capacity as it prepares for the "back-to-school" season for Qelbree.
Product Pipeline Update

R&D Day

On October 18, 2023, Supernus will host an R&D Day in New York City. The management team plans to provide an overview of the Company’s pipeline, with emphasis on SPN-820/821, SPN-817 and new clinical candidates from the Company’s discovery program. In addition, key thought leaders will share their perspectives on the current treatment paradigms, unmet medical needs, and the Company’s clinical development programs. Further details are forthcoming.
SPN-830 (apomorphine infusion device) – Continuous treatment of motor fluctuations ("off" episodes) in Parkinson’s disease (PD)

The Company continues to expect to resubmit the New Drug Application for SPN-830 in the fourth quarter of 2023.
SPN-820/821 – Novel first-in-class activator of mTORC1 for the treatment of treatment-resistant depression

The Phase II multi-center randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment-resistant depression is ongoing. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score, a standard depression rating scale.
SPN-817 – A novel product candidate for the treatment of epilepsy

The open-label Phase II clinical study of SPN-817 in patients with treatment-resistant seizures is ongoing. Depending on the rate of enrollment, the Company expects to have data in the first half of 2024.
Financial Highlights

Total revenues

For the three months ended June 30, 2023, total revenues and total net product sales were $135.5 million and $128.3 million, respectively, compared to total revenues and total net product sales of $170.1 million and $165.5 million for the same periods in 2022. For the six months ended June 30, 2023, total revenues and total net product sales were $289.3 million and $268.9 million, respectively, compared to total revenues and total net product sales of $322.5 million and $312.9 million for the same periods in 2022. The decrease in net product sales in both periods was primarily due to the decline in net product sales of Trokendi XR, partially offset by an increase in net product sales of both Qelbree and GOCOVRI.

Excluding net product sales of Trokendi XR, total revenues for the three and six months ended June 30, 2023, increased 18% and 25%, respectively, compared to the same periods last year.

The following table provides information regarding total revenues during the three and six months ended June 30, 2023 and 2022 (unaudited, dollars in millions):

Three Months Ended June 30, Six Months Ended June 30,
2023 2022 Change % 2023 2022 Change %
Total net product sales $ 128.3 $ 165.5 (22 )% $ 268.9 $ 312.9 (14 )%
Royalty revenues (1) 7.2 4.6 57 % 20.4 9.6 113 %
Total revenues $ 135.5 $ 170.1 (20 )% $ 289.3 $ 322.5 (10 )%
Total revenues excluding Trokendi XR net product sales (2) $ 116.2 $ 98.5 18 % $ 235.2 $ 188.1 25 %
___________________________________________
(1) Royalty revenues include royalties on generic Trokendi XR, other licensed products and intellectual property.
(2) Total revenues, excluding Trokendi XR net product sales is a non-GAAP measure. Refer to "Non-GAAP Financial Information" below for a description of its calculation.

The following table provides information regarding total net product sales during the three and six months ended June 30, 2023 and 2022 (unaudited, dollars in millions):

Three Months Ended June 30, Six Months Ended June 30,
2023 2022 Change % 2023 2022 Change %
Net product sales
Qelbree $ 31.0 $ 11.1 179 % $ 56.8 $ 19.4 193 %
GOCOVRI 28.8 24.7 17 % 54.8 47.3 16 %
Oxtellar XR 23.8 30.0 (21 )% 52.7 57.5 (8 )%
Trokendi XR 19.3 71.6 (73 )% 54.1 134.4 (60 )%
APOKYN 17.6 20.4 (14 )% 34.8 38.9 (11 )%
Other(1) 7.8 7.7 1 % 15.7 15.4 2 %
Total net product sales $ 128.3 $ 165.5 (22 )% $ 268.9 $ 312.9 (14 )%
___________________________________________
(1) Includes net product sales of MYOBLOC, XADAGO and Osmolex ER.

Operating earnings (loss) (GAAP and non-GAAP)

For the three months ended June 30, 2023, operating loss (GAAP) was ($17.6) million, compared to operating earnings (GAAP) of $11.3 million for the same period in 2022. For the six months ended June 30, 2023, operating loss (GAAP) was ($12.4) million, compared to operating earnings (GAAP) of $13.3 million for the same period in 2022. The operating loss (GAAP) in both periods in 2023 was primarily due to a decrease in net product sales of Trokendi XR, partially offset by growth in net product sales of Qelbree and GOCOVRI, an increase in royalty revenues and a decrease in operating expenses.

For the three months ended June 30, 2023, adjusted operating earnings (non-GAAP) were $10.0 million, compared to $37.6 million for the same period in 2022. For the six months ended June 30, 2023, adjusted operating earnings (non-GAAP) were $40.5 million, compared to $65.7 million for the same period in 2022.

Reconciliation of GAAP to Non-GAAP Operating earnings (loss)

An itemized reconciliation between operating earnings (loss) on a GAAP basis and operating earnings on a non-GAAP basis is as follows (unaudited, dollars in millions):

Three Months Ended June 30, Six Months Ended June 30,
2023 2022 2023 2022
Operating earnings (loss) – As Reported (GAAP) $ (17.6 ) $ 11.3 $ (12.4 ) $ 13.3
Adjustments:
Amortization of intangible assets 20.1 20.6 40.1 41.3
Share-based compensation 6.1 4.3 12.4 8.3
Contingent consideration expense (gain) 0.8 0.7 (0.9 ) 1.4
Depreciation 0.6 0.7 1.3 1.4
Operating earnings – As Adjusted (non-GAAP) $ 10.0 $ 37.6 $ 40.5 $ 65.7

Non-GAAP operating earnings adjusts for non-cash items including amortization of intangible assets, share-based compensation expense, change in fair value of contingent consideration, and depreciation.

Net earnings (loss) (GAAP)

For the three months ended June 30, 2023, net earnings (loss) (GAAP) and diluted earnings (loss) per share (GAAP) were ($0.8) million and ($0.02), respectively, as compared to $7.9 million and $0.14, in the same period in 2022. For the six months ended June 30, 2023, net earnings (GAAP) and diluted earnings per share (GAAP) were $16.1 million and $0.29, respectively, as compared to $33.5 million and $0.57 in the same period in 2022.

Balance sheet

At June 30, 2023, the Company’s cash, cash equivalents, and current and long-term marketable securities were approximately $189.1 million, compared to $555.2 million as of December 31, 2022. This decrease was primarily due to repayment of the 0.625% Convertible Senior Notes due 2023 (2023 Notes), partially offset by cash generated from operations.

On April 1, 2023, the Company paid the total principal amount of $402.5 million due under its 2023 Notes, in addition to payment of the remaining outstanding interest of $1.3 million. Following the repayment, the 2023 Notes are no longer outstanding. In addition, as of June 30, 2023, the Company has fully repaid the $93 million borrowing against the credit line.

Full Year 2023 Financial Guidance (GAAP)

For the full year 2023, the Company reiterates its prior financial guidance as set forth below (dollars in millions).

Amount
Total revenues (1) (Includes $70 million to $80 million of Trokendi XR(2)) $580 – $620
Combined R&D and SG&A expenses $450 – $480
Operating loss (3) $(30) – $(10)
___________________________________________
(1) Includes net product sales and royalty revenue.
(2) Reflects Trokendi XR generic erosion in 2023.
(3) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating loss on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows (dollars in millions):

Amount
Operating loss – GAAP $(30) – $(10)
Adjustments:
Amortization of intangible assets $83
Share-based compensation $20 – $24
Contingent consideration $0 – $1
Depreciation $2
Operating earnings – non-GAAP $75 – $100

Supplemental Revenue Reconciliation (unaudited)

Three Months Ended June 30, Six Months Ended June 30,
2023 2022 Change % 2023 2022 Change %
Total revenues (GAAP) (1) $ 135.5 $ 170.1 (20 )% $ 289.3 $ 322.5 (10 )%
Less: Trokendi XR net product sales 19.3 71.6 (73 )% 54.1 134.4 (60 )%
Total revenues excluding Trokendi XR net product sales (Non-GAAP) $ 116.2 $ 98.5 18 % $ 235.2 $ 188.1 25 %
___________________________________________
(1) Includes net product sales and royalty revenue.

On August 8, 2023 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the second quarter of 2023 and raised full-year 2023 guidance for Adjusted Cash Receipts(1) (a non-GAAP financial measure) (Press release, Royalty Pharma , AUG 8, 2023, View Source [SID1234633991]).

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"We reported another quarter of strong financial performance as we continued to execute on our strategy," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "We remain very confident in our outlook based on our growth drivers, broad portfolio and robust deal pipeline. This year, we have already announced transactions of up to $1.7 billion, taking our total to $10 billion since our June 2020 IPO. This underscores our strong momentum in scaling the business and further cements our leadership position in the biopharma royalty market. Furthermore, as part of our balanced capital allocation strategy, we began repurchasing our Class A ordinary shares under our share repurchase program, which reflects our attractive prospects for compounding growth."

Second quarter 2023 GAAP financial results demonstrate solid operating cash flow growth

Net cash provided by operating activities grew 6% to $608 million; Net cash used in investing activities was $63 million; Net cash used in financing activities was $347 million.
Total income and other revenues were $538 million.
Second quarter 2023 non-GAAP financial results show continued business momentum

Adjusted Cash Receipts(1) increased 4% to $545 million, driven by strong portfolio performance and new royalties, partially offset by royalty expirations, Imbruvica headwinds and unfavorable foreign exchange movements; Adjusted Cash Receipts(1) grew 7% prior to the Biohaven related fixed payment received in the prior year period.
Adjusted EBITDA(2) grew 4% to $498 million; Adjusted Cash Flow(3) increased 6% to $512 million.
Positive business updates during the second quarter 2023

Johnson & Johnson reported positive Phase 3 results for Tremfya in ulcerative colitis; Gilead announced approval of Trodelvy in pre-treated HR+/HER2- metastatic breast cancer in Europe.
Purchased incremental royalty on Johnson & Johnson’s Erleada.
Increasing mid-point of financial guidance range for 2023 (excludes contributions from new transactions)

Royalty Pharma now anticipates 2023 Adjusted Cash Receipts(1) (non-GAAP) to be between $2,900 million and $2,975 million (previously $2,850 million to $2,950 million), excluding future transactions.
This guidance represents underlying growth of 6%(4) to 10%(4) prior to the Zavzpret milestone payment in 2023 and payments related to the Biohaven Preferred Shares in 2022.
Financial Summary Three Months Ended June 30,
(unaudited)
($ and shares in millions) 2023 2022 Change
Net cash provided by operating activities (GAAP) 608 575 6%
Net cash used in investing activities (GAAP) (63) (30) 110%
Net cash used in financing activities (GAAP) (347) (228) 52%
Total income and other revenues (GAAP) 538 536 0%
Adjusted Cash Receipts(1) (non-GAAP) 545 524 4%
Adjusted EBITDA(2) (non-GAAP) 498 480 4%
Adjusted Cash Flow(3) (non-GAAP) 512 482 6%
Weighted average Class A ordinary shares outstanding – diluted 606 607 0%

Second Quarter 2023 Financial Results

Three Months Ended June 30,
(unaudited)
($ in millions) 2023 2022 Change
Net cash provided by operating activities (GAAP) 608 575 6%
Royalties: Marketers: Therapeutic Area:
Cystic fibrosis franchise Vertex Rare disease 206 182 13%
Tysabri Biogen Neurology 84 93 (9)%
Imbruvica AbbVie, J&J Cancer 63 80 (22)%
Xtandi Pfizer, Astellas Cancer 40 52 (22)%
Promacta Novartis Hematology 39 35 12%
Trelegy GSK Respiratory 37 — n/a
Tremfya Johnson & Johnson Immunology 22 18 21%
Cabometyx/Cometriq Exelixis, Ipsen, Takeda Cancer 15 13 18%
Prevymis Merck & Co. Infectious disease 14 10 38%
Evrysdi Roche Rare disease 13 8 60%
Spinraza Biogen Neurology 13 — n/a
Farxiga/Onglyza AstraZeneca Diabetes 10 11 (10)%
Trodelvy Gilead Cancer 9 6 52%
Erleada Johnson & Johnson Cancer 7 5 37%
Orladeyo BioCryst Rare disease 7 5 38%
Crysvita Ultragenyx, Kyowa Kirin Rare disease 5 5 5%
Emgality Lilly Neurology 4 4 0%
Nurtec ODT/Biohaven payment* Pfizer Neurology 4 19 (78)%
Other products(5) 45 86 (48)%
Total royalty receipts 637 633 1%
Distributions to legacy non-controlling interests – royalty receipts (92) (109) (15)%
Adjusted Cash Receipts(1) (non-GAAP) 545 524 4%
Amounts shown in the table may not add due to rounding.
* In 2022, royalty receipts include the $16 million quarterly redemption payment related to the Series A Biohaven Preferred Shares(6) (presented as Proceeds from available for sale debt securities on the statement of cash flows). The Series A Biohaven Preferred Shares were fully redeemed in October 2022 following Pfizer’s acquisition of Biohaven. The remaining amounts, which relate to ongoing royalty receipts from Nurtec ODT, increased by 35% in second-quarter 2023 versus the prior year period.

Net cash provided by operating activities (GAAP) was $608 million in the second quarter of 2023, an increase of 6% compared to $575 million in the same period of 2022. The increase was largely attributable to the performance of the cystic fibrosis franchise and the additions of Trelegy and Spinraza royalties. The increase was partially offset by lower cash collections from Januvia, Janumet and other DPP-IVs, which substantially ended in the second quarter of 2022, and declines in Imbruvica and Xtandi royalties, the latter of which faced a high base of comparison due to a true-up of royalties received in the prior year period.

Total royalty receipts were $637 million in the second quarter of 2023, an increase of 1% compared to $633 million in the same period of 2022. The drivers of the increase in total royalty receipts are the same as noted above for Net cash provided by operating activities.

Drivers of total royalty receipts in the second quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter). The section below excludes comments from marketers on the impact of foreign exchange rates, which was generally a modest headwind across the portfolio. Refer to Table 6 for a description of approved indications.

Cystic fibrosis franchise* ($206 million, +13%) Driven by the strong uptake of Kaftrio outside the United States, including its uptake in children ages 6 through 11, and the continued performance of Trikafta in the U.S.
Tysabri ($84 million, -9%) Decrease largely driven by pricing pressure, competition and channel dynamics.
Imbruvica ($63 million, -22%) Performance was impacted by increased competition and the cumulative impact of a suppressed chronic lymphocytic leukemia market.
Xtandi ($40 million, -22%) Decrease driven by a high base of comparison from a true-up of royalties received in the second quarter of 2022, which negatively impacted year-over-year growth by 29%. Xtandi continued to maintain strong sales performance in markets outside the U.S.
Promacta ($39 million, +12%) Driven by increased use in chronic immune thrombocytopenia purpura and as a first- and/or second-line treatment for severe aplastic anemia.
Trelegy ($37 million, n/a) Benefited from increased patient demand globally and growth of the single inhaler triple therapy market. Royalty Pharma acquired a royalty interest in Trelegy in July 2022 and began receiving royalty receipts in the third quarter of 2022.
Tremfya ($22 million, +21%) Driven by market growth and market share gains in psoriasis and psoriatic arthritis, partially offset by unfavorable patient mix.
Cabometyx / Cometriq ($15 million, +18%) Increase primarily due to uptake in combination with Opdivo as a first-line treatment for patients with advanced renal cell carcinoma.
Evrysdi ($13 million, +60%) Experienced strong growth globally, driven by switch and treatment naive patient starts in the U.S. and share gains in all major markets outside the U.S.
Spinraza ($13 million, n/a) Increase primarily driven by growth outside the U.S., offset by fewer new patient starts and channel dynamics in the U.S. Royalty Pharma acquired the Spinraza royalty in the first quarter of 2023.
Trodelvy ($9 million, +52%) Driven by increased adoption in metastatic triple-negative breast cancer
in the U.S. and Europe, as well as the launch of the indication for pretreated HR+/HER2- metastatic breast cancer in the U.S.
Orladeyo ($7 million, +38%) Driven by strong new patient growth in the U.S. and an acceleration in the launch of Orladeyo outside the U.S.
Nurtec ODT/Biohaven payment ($4 million, -78%) Impacted by prior year comparisons as Royalty Pharma no longer receives Series A Preferred Shares redemption payments following Pfizer’s acquisition of Biohaven in the fourth quarter 2022. Underlying Nurtec ODT royalties increased $1 million, or 35%, compared to the prior year period, driven by strong growth in demand.
Percentages shown represent year-over-year changes.
*Includes Kalydeco, Orkambi, Symdeko/Symkevi and Trikafta/Kaftrio.

Distributions to legacy non-controlling interests – royalty receipts, which reduce royalty receipts to arrive at Adjusted Cash Receipts(1), were $92 million in the second quarter of 2023, a decrease of 15% compared to the same period of 2022. The decrease was largely due to reduced royalties from maturing or expired products, such as Januvia, Janumet and other DPP-IVs, where the percentage of royalties attributed to non-controlling interests is higher. As a percentage of total royalty receipts, distributions to legacy non-controlling interests – royalty receipts decreased to 15% in the second quarter of 2023, compared to 17% in the prior year period. In addition to reduced royalties from maturing or expired products, the decrease as a percentage of total royalty receipts was also driven by the additions of Trelegy and Spinraza, which have no distributions to legacy non-controlling interests.

Adjusted Cash Receipts(1) (non-GAAP) were $545 million in the second quarter of 2023, an increase of 4% compared to $524 million for the same period of 2022, reflecting higher royalty receipts from existing products, including the cystic fibrosis franchise, the additions of Trelegy and Spinraza and a decrease in distributions to legacy non-controlling interests. This increase was partially offset by a decline in royalty receipts from maturing royalties, lower royalties on Imbruvica and Xtandi, the end of redemption payment related to the Biohaven Series A Preferred Shares, as well as from unfavorable foreign exchange movements. Prior to the Biohaven related redemption payment in the second quarter of 2022, Adjusted Cash Receipts(1) growth was 7% in the second quarter of 2023 compared to the prior year period.

Adjusted EBITDA(2) (non-GAAP) is comprised of Adjusted Cash Receipts(1) less payments for operating and professional costs. Adjusted EBITDA(2) was $498 million in the second quarter of 2023, an increase of 4% compared to Adjusted EBITDA(2) of $480 million in the second quarter of 2022, and was largely attributable to growth in Adjusted Cash Receipts(1). Additionally, payments for operating and professional costs of $47 million (representing 9% of Adjusted Cash Receipts(1)) in the second quarter of 2023 increased by 7% compared to the $44 million reported in the same period of 2022 (representing 8% of Adjusted Cash Receipts(1)). Prior to the Biohaven related redemption payment in the second quarter of 2022, Adjusted EBITDA(2) growth was 6% in the second quarter of 2023 compared to the year ago period.

Adjusted Cash Flow(3) (non-GAAP) is comprised of Adjusted EBITDA(2) less Development-stage funding payments – ongoing, Development-stage funding payments – upfront and milestone, net interest received and miscellaneous other items. In the second quarter of 2023, Adjusted Cash Flow(3) was $512 million, a 6% increase compared to $482 million for the same period of 2022. The increase in Adjusted Cash Flow(3) was primarily due to growth in Adjusted EBITDA(2) and higher net interest received. Prior to the Biohaven related redemption payment in the second quarter of 2022, Adjusted Cash Flow(3) growth was 9% in the second quarter of 2023 compared to the prior year period.

A more comprehensive discussion of the non-GAAP measures utilized by Royalty Pharma to manage its business can be found in the section of this press release entitled ‘Use of Non-GAAP Measures’.

Key Developments Relating to the Portfolio

The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.

Trodelvy In July 2023, Gilead announced the European Commission approved Trodelvy as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer.
Cystic fibrosis franchise In July 2023, Vertex announced the European Commission approved the label extension of Orkambi for the treatment of children with cystic fibrosis ages 1 to less than 2 years old.
In May 2023, Vertex announced the U.S. Food and Drug Administration ("FDA") approved Kalydeco for use in children with cystic fibrosis ages 1 month to less than 4 months old.
In April 2023, Vertex announced the FDA approved the expanded use of Trikafta to include children with cystic fibrosis ages 2 through 5 years.
Xtandi In June 2023, Pfizer announced the FDA approved Talzenna in combination with Xtandi for the treatment of adult patients with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer.
In April 2023, Pfizer and Astellas announced that Xtandi plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide, as assessed by the primary endpoint of metastasis-free survival in men with non-metastatic hormone-sensitive prostate cancer. A positive trend in the key secondary endpoint of overall survival was also observed in the Xtandi combination arm at the time of the analysis, but these data were not yet mature. Patients in the trial will be followed for a subsequent final overall survival analysis.
Tremfya In May 2023, Johnson & Johnson announced positive results from the Phase 3 QUASAR Induction Study evaluating the investigational use of Tremfya in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional and/or advanced therapies. The data showed statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures, as well as a greater proportion of patients treated with Tremfya compared to placebo achieved clinical remission at week 12, the study’s primary endpoint.
Summary of Recent Royalty Acquisition Activity

Royalty Pharma has announced new transactions of up to $1.7 billion year-to-date, including $659 million in upfront payments. Recent transactions include:

In June 2023, Royalty Pharma acquired an incremental royalty interest in Erleada from the Regents of the University of California.
Liquidity and Capital Resources

As of June 30, 2023, Royalty Pharma had cash and cash equivalents of $2.2 billion and total debt with principal value of $7.3 billion.
During the second quarter of 2023, Royalty Pharma began repurchasing its Class A ordinary shares and repurchased approximately four million shares for $134 million. Through August 7, 2023, Royalty Pharma has repurchased approximately six million shares for $185 million. The weighted-average diluted Class A ordinary shares outstanding for the second quarter of 2023 was 606 million as compared to 607 million for the first quarter of 2023.
2023 Financial Outlook

Royalty Pharma has provided its guidance for full year 2023, excluding transactions announced after the date of this release, as follows:

Provided August 8, 2023 Previous
Adjusted Cash Receipts(1) (non-GAAP) $2,900 million to $2,975 million $2,850 million to $2,950 million
Payments for operating and professional costs 8.0% to 8.5% of Adjusted Cash Receipts(1) 8% to 9% of Adjusted Cash Receipts(1)
Interest paid $170 million $170 million
Development-stage funding payments – upfront and milestone $50 million $50 million
This Adjusted Cash Receipts(1) guidance represents underlying growth of 6%(4) to 10%(4) prior to the Zavzpret milestone payment in the first quarter of 2023 and the payments related to the Biohaven Preferred Shares received in 2022.

Additionally, this guidance reflects an estimated foreign exchange impact of approximately -1%(10) to -2%(10) for full year 2023 Adjusted Cash Receipts(1) growth, assuming current foreign exchange rates prevail for 2023.

Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and is anticipated to be approximately $170 million in 2023. Interest paid is anticipated to be approximately $85 million in the third quarter of 2023 with a de minimis amount recorded in the fourth quarter. The projection assumes no incremental debt financing in 2023. Through the first six months of 2023, Royalty Pharma also received interest of $35 million on its cash and cash equivalents, which partially offset interest paid.

Royalty Pharma today provides this guidance based on its most up-to-date view on its prospects. This guidance assumes no major unforeseen adverse events and excludes the contributions from transactions announced subsequent to the date of this press release. Furthermore, Royalty Pharma may amend its guidance in the event it engages in new royalty transactions which have a material near-term financial impact on the company.

Royalty Pharma has not reconciled its non-GAAP 2023 guidance to the most directly comparable GAAP measure, net cash provided by operating activities, at this time due to the inherent difficulty in accurately forecasting and quantifying certain amounts that are necessary for such reconciliation, including, primarily, payments for operating and professional costs, distributions from equity method investees and interest received. Royalty Pharma is not able to forecast on a GAAP basis with reasonable certainty all adjustments needed in order to project net cash provided by operating activities at this time.

Financial Results Call

Royalty Pharma will host a conference call and simultaneous webcast to discuss its second quarter 2023 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

On August 8, 2023 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported its financial results for the quarter ended June 30, 2023, and provided an update on corporate progress (Press release, Revolution Medicines, AUG 8, 2023, View Source [SID1234633990]).

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"With growing confidence in our pioneering RAS-focused drug candidate pipeline, we believe Revolution Medicines is poised for a transformative second half of the year. We intend to share significant clinical updates on our most advanced RAS(ON) Inhibitors, RMC-6236 and RMC-6291, through oral presentations at the Triple Meeting and ESMO (Free ESMO Whitepaper) in October," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Having announced last week our agreement to acquire EQRx to add more than $1 billion in additional capital to our balance sheet, we are in an especially strong position to build on this clinical momentum and continue scientific advances on behalf of patients. We are already planning one or more pivotal single agent clinical trials for RMC-6236 as well as for our first in-pipeline combination trial featuring RMC-6236 and RMC-6291."

Clinical and Development Highlights

Investigational RAS(ON) Inhibitors

RMC-6236 (RASMULTI)
RMC-6236 is an oral, RAS-selective, first-in-class RAS(ON) Inhibitor designed to treat patients with cancers driven by a wide range of common RAS mutations. Initially being evaluated as monotherapy, it may also be evaluated as a RAS Companion Inhibitor in combination with mutant-selective RAS(ON) Inhibitors and in other combination treatments.

The ongoing Phase 1/1b monotherapy trial (NCT05379985) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-6236 in patients with advanced solid tumors harboring select KRASG12 mutations, including KRASG12D, KRASG12V and KRASG12R. Preliminary data have shown promising evidence of anti-tumor activity at generally well tolerated dose levels. A maximum tolerated dose has not yet been defined and dose escalation is ongoing.
An update on the clinical antitumor activity of RMC-6236 in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer will be presented as a Proffered Paper (oral presentation) during the Developmental Therapeutics session on Sunday, October 22 at the European Society for Medical Oncology Congress 2023 (ESMO) (Free ESMO Whitepaper), and supporting clinical data will be presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Triple Meeting) in October 2023. Additional details for these presentations will be provided when available.
Based on encouraging data trends thus far for RMC-6236, planning is underway for one or more single agent pivotal clinical trials potentially to begin in 2024.
RMC-6291 (KRASG12C)
RMC-6291, an oral, covalent inhibitor of KRASG12C(ON) designed to treat patients with cancers driven by the KRASG12C mutant, is the first of the company’s mutant-selective RAS(ON) Inhibitors to enter clinical development and the first reported clinical-stage inhibitor of KRASG12C that uses a highly differentiated mechanism of action compared to first-generation compounds.

The ongoing Phase 1/1b monotherapy trial (NCT05462717) is a multicenter, open-label, dose-escalation and dose-expansion study of RMC-6291 in patients with advanced KRASG12C mutant solid tumors. Early findings have shown that RMC-6291 is orally bioavailable, exhibits pharmacokinetics consistent with preclinical findings, and is generally well tolerated in a pharmacologically active range.
The company will provide a first report on initial clinical findings with RMC-6291, including preliminary evidence of differentiation from RAS(OFF) inhibitors, at the Triple Meeting. Details for this presentation will be provided when available.
With encouraging initial clinical experience thus far for RMC-6291, planning is underway for a Phase 1/1b clinical trial to evaluate the combination of RMC-6236 and RMC-6291 potentially to begin in early 2024, in parallel to the continuing single agent evaluation of RMC-6291.
RMC-9805 (KRASG12D)
RMC-9805 is an oral, selective, covalent inhibitor of KRASG12D(ON), the most common driver of RAS-addicted human cancers, predominantly among patients with pancreatic cancer, NSCLC, or colorectal cancer (CRC). The company believes RMC-9805 is the first oral, mutant-selective and covalent inhibitor of KRASG12D.

Study site activation is ongoing under an investigational new drug (IND) application for a monotherapy dose-escalation Phase 1/1b trial of RMC-9805 and the company currently expects to announce dosing of the first patient in this study in the second half of 2023.
RAS Innovation Engine
Beyond the first wave of RAS(ON) Inhibitors, the company continues expanding its preclinical pipeline of RAS(ON) Inhibitor candidates.

RMC-0708 is a potent, oral, selective, first-in-class non-covalent inhibitor of the KRASQ61H(ON) cancer variant. KRASQ61H is found in lung cancer, CRC, pancreatic cancer, and multiple myeloma. RMC-0708 is the company’s first mutant-selective RAS(ON) Inhibitor drug candidate to engage its RAS target non-covalently.
RMC-8839 is a potent, oral, and selective inhibitor of KRASG13C(ON). The company believes RMC-8839 is the first compound to selectively inhibit KRASG13C, an important therapeutic target primarily for NSCLC and select CRC patients unserved by a targeted RAS inhibitor.
The company continues drug discovery efforts in RAS(ON) Inhibitor pipeline expansion programs focused on RAS mutation hotspots including KRASG12R, KRASG13D, and other important targets.
Investigational RAS Companion Inhibitors

RMC-4630 (SHP2)
RMC-4630 is a clinical-stage, oral inhibitor of SHP2, which contributes to tumor survival and growth in many RAS-addicted cancers.

RMC-4630 and KRASG12C Inhibitor Lumakras (sotorasib)

RMC-4630-03 (NCT05054725) is a global, multicenter, open-label Phase 2 study of RMC-4630 in combination with sotorasib for patients with NSCLC with a KRASG12C mutation who have failed prior standard therapy and who have not previously been treated with a KRASG12C inhibitor that the company is conducting in collaboration with Amgen.
The RMC-4630-03 study is fully enrolled, and the company plans to review a complete data set from the study when available. Decisions about future development of RMC-4630 will take into account this analysis and other considerations, including the potential of RMC-6236 as a RAS Companion Inhibitor. The company no longer plans to share topline data from the RMC-4630-03 study prior to disclosing decisions about future development of the compound.
RMC-5552 (mTORC1/4EPB1)
RMC-5552 is a first-in-class, bi-steric mTORC1-selective inhibitor designed to suppress phosphorylation and inactivation of 4EBP1 in cancers with hyperactive mTORC1 signaling, including certain RAS-addicted cancers. The company plans to evaluate RMC-5552 in combination with RAS(ON) inhibitors for patients with cancers harboring a RAS mutation and co-occurring mutations in the mTOR signaling pathway.

Dose optimization continues in the company’s ongoing multicenter, open-label, Phase 1/1b dose-escalation study evaluating RMC-5552 monotherapy in patients with refractory solid tumors (NCT04774952).
The company currently expects to provide additional characterization of the single agent profile for this compound at the upcoming Triple Meeting in October 2023.
Corporate Highlights

Acquisition of EQRx

On August 1, 2023, the company announced it entered into a definitive agreement to acquire EQRx, Inc. in an all-stock transaction intended to add more than $1 billion in net cash to the company’s balance sheet.
This proposed transaction is intended to reinforce and sustain Revolution Medicines’ parallel development approach for its extensive RAS(ON) Inhibitor pipeline in multiple RAS-driven cancers by enhancing its balance sheet.
The merger is expected to close in November 2023, subject to satisfaction of customary closing conditions, including regulatory review, and approval by Revolution Medicines’ and EQRx’s stockholders. Additional details can be found in the announcement press release as well as in Revolution Medicines’ and EQRx’s SEC filings.
Second Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $909.5 million as of June 30, 2023, compared to $644.9 million as of December 31, 2022. The increase was primarily attributable to the company’s public equity offering in March 2023.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $3.8 million for the quarter ended June 30, 2023, compared to $9.1 million for the quarter ended June 30, 2022.

R&D Expenses: Research and development expenses were $98.0 million for the quarter ended June 30, 2023, compared to $61.0 million for the quarter ended June 30, 2022. The increase was primarily due to an increase in clinical trial and clinical supply manufacturing expenses for RMC-6236 and RMC-6291, research expenses associated with the company’s pre-clinical portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

G&A Expenses: General and administrative expenses were $14.6 million for the quarter ended June 30, 2023, compared to $10.2 million for the quarter ended June 30, 2022. The increase was primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount.

Net Loss: Net loss was $98.3 million for the quarter ended June 30, 2023, compared to net loss of $61.2 million for the quarter ended June 30, 2022.

Financial Guidance
Revolution Medicines is reiterating its projected full year 2023 GAAP net loss to be between $360 and $400 million, which includes estimated non-cash stock-based compensation expense of $40 million and $50 million. Based on the company’s current operating plan, the company projects current cash, cash equivalents and investments can fund planned operations into 2025. The Company’s financial guidance excludes the financial impact of the proposed EQRx transaction.

Webcast
Revolution Medicines will host a webcast this afternoon, August 8, 2023, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On August 8, 2023 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported second quarter 2023 financial results and corporate highlights (Press release, Relay Therapeutics, AUG 8, 2023, View Source [SID1234633989]).

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"In the second quarter of 2023, we continued to advance our pipeline and progress our breast cancer portfolio," said Sanjiv Patel, M.D., president and chief executive officer of Relay Therapeutics. "In July, we initiated the first RLY-2608 + fulvestrant dose expansion cohort. The additional RLY-2608 data supporting this decision, and the breadth of our breast cancer franchise, continue to drive our confidence that we are building a comprehensive solution for the more than 100,000 patients diagnosed with PI3Kα-mutated breast cancer in the U.S. each year."

RLY-2608 Update

In July 2023, initiated dose expansion cohort with RLY-2608 600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2– locally advanced or metastatic breast cancer

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Selection of 600mg BID dose supported by updated data from 17 breast cancer patients treated with RLY-2608 600mg BID + fulvestrant (cut-off date of July 24, 2023)
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Interim clinical benefit rate (CBR) of 86 percent (6 of 7 CBR-evaluable patients) (CBR defined as the proportion of patients with stable disease, complete response, or partial response for at least 24 weeks)
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Fifteen of 17 patients remain on treatment as of the cut-off date
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One of five efficacy-evaluable patients with measurable disease achieved a confirmed partial response (PR) and remains on treatment as of the cut-off date (helical mutation)
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Interim safety data compelling for use in metastatic breast cancer combinations
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Overall, updated data strengthen the RLY-2608 profile and continue to support selective target engagement across doses and mutation types with favorable interim safety and tolerability data. As of the July 24th data cut-off, 43 total breast cancer patients had received RLY-2608 monotherapy (n=4) or RLY-2608 + fulvestrant (n=39)

Four of 24 efficacy-evaluable patients with measurable disease achieved PRs, including three confirmed (400mg BID mono with double mutation; 100mg BID combo with kinase mutation; 600mg BID combo with helical mutation) and one unconfirmed (800mg BID combo with helical mutation)
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The interim safety profile of RLY-2608 remains consistent with safety data previously reported at AACR (Free AACR Whitepaper)
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No adverse event-related discontinuations
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No Grade 3+ hyperglycemia or diarrhea
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Data from ongoing dose escalation arms could support decision to bring an additional dose into dose expansion in the future
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Next data update expected in 2024

Additional Recent Corporate Highlights

RLY-4008

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Presented full dose escalation data from the ReFocus study at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Anticipated Upcoming Milestones

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RLY-4008
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Complete enrollment of pivotal cohort in the second half of 2023
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Data from non-CCA expansion cohorts in the second half of 2023
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RLY-2608
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Next data update expected in 2024
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ERα degrader: development candidate nomination in 2023
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RLY-2139 (selective CDK2 inhibitor): clinical start in early 2024, pending regulatory authorization

Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2023, cash, cash equivalents and investments totaled $871.6 million compared to approximately $1 billion as of December 31, 2022. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2025.

R&D Expenses: Research and development expenses were $88.2 million for the second quarter of 2023, as compared to $60.5 million for the second quarter of 2022. The increase was primarily due to $13.6 million of additional clinical trial expenses and $9.3 million of additional employee-related costs, which include $5.0 million of additional stock-based compensation expense.

G&A Expenses: General and administrative expenses were $20.1 million for the second quarter of 2023, as compared to $17.5 million for the second quarter of 2022. The increase was primarily due to additional employee-related costs, which include $3.3 million of additional stock-based compensation expense.

Net Loss: Net loss was $98.5 million for the second quarter of 2023, or a net loss per share of $0.81, as compared to a net loss of $76.8 million for the second quarter of 2022, or a net loss per share of $0.71.

On August 8, 2023 Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, reported business updates and financial results for its second quarter ending June 30, 2023 (Press release, Recursion Pharmaceuticals, AUG 8, 2023, View Source [SID1234633988]).

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"As the world continues to undergo a revolution in artificial intelligence and computation, Recursion is leading the TechBio sector with one of the most advanced technology-enabled drug discovery platforms in the industry," said Chris Gibson, Ph.D., Co-Founder and CEO of Recursion. "Our recent acquisitions of Cyclica and Valence and our new partnership with NVIDIA bring industry-leading capabilities to our platform that have already delivered significant value across our pipeline and partnerships. With multiple clinical catalysts in the coming quarters, the extraordinary progress in our technology, and the commitment of our teams, Recursion is making its vision of industrialized drug discovery real day by day."

Summary of Business Highlights
•Pipeline
◦Cerebral Cavernous Malformation (CCM) (REC-994): Our Phase 2 SYCAMORE clinical trial is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this drug candidate in participants with CCM.

This study was fully enrolled as of June 2023 with 62 participants and all participants who have thus far finished their first year of treatment have enrolled in the long-term extension study. We expect to share Phase 2 proof-of-concept data in H2 2024.
◦Neurofibromatosis Type 2 (NF2) (REC-2282): Our Phase 2/3 POPLAR clinical trial is a two part study of REC-2282 in participants with progressive NF2-mutated meningiomas. Part A of the study is ongoing and is exploring two doses of REC-2282 in approximately 23 adults and 9 adolescents.We expect to share Phase 2 safety, tolerability, pharmacokinetics and preliminary efficacy in H2 2024.
◦Familial Adenomatous Polyposis (FAP) (REC-4881): We have enrolled multiple participants in our TUPELO clinical trial which evaluates REC-4881 in patients with FAP. We are now providing guidance on a data readout and expect to share Phase 2 safety, tolerability, pharmacokinetics and preliminary efficacy in H1 2025.
◦AXIN1 or APC Mutant Cancers (REC-4881): We will evaluate REC-4881 in a Phase 2 biomarker enriched study in patients with unresectable, locally advanced or metastatic cancer with AXIN1 or APC mutations. The IND was accepted by the FDA and we expect to initiate this Phase 2 study in Q4 2023.
◦Clostridioides difficile Infection (REC-3964): Our Phase 1 clinical trial is a first-in-human protocol evaluating single and multiple doses of REC-3964 in healthy volunteers and will assess the safety, tolerability and pharmacokinetic profile of REC-3964. Single ascending dose and multiple ascending dose studies are now complete. REC-3964 has been well tolerated and no safety issues have been identified to date. We expect to share Phase 1 safety and pharmacokinetics data in Q3 2023.
◦RBM39 HR-Proficient Ovarian Cancer: RBM39 (previously identified as Target Gamma) is a novel CDK12-adjacent target identified by the Recursion OS. We believe we can modulate this target to produce a therapeutic effect in HR-proficient ovarian cancer and potentially in other tumor types. This program is in the preclinical stage and IND-enabling studies are progressing.
•Partnerships
◦NVIDIA: In July 2023, we announced a $50 million investment and collaboration with NVIDIA. We will continue to build our own foundation models for biology and chemistry and NVIDIA will assist in optimizing these models, provide priority access to computational resources on NVIDIA’s cloud service DGX Cloud, and potentially host commercially-licensable machine learning and foundation models developed by Recursion on BioNeMo, NVIDIA’s marketplace for generative AI in drug discovery. In this partnership, we will maintain control of our proprietary data and models as well as how and where we could host our technology tools as we expand our business strategy of data as a value driver. Since the announcement in July, we have already deployed our digital chemistry technology together with NVIDIA’s computational resources to predict the ligand-protein interactions for approximately 36 billion compounds in the Enamine REAL Space, reported to be the world’s largest searchable chemical library, where we evaluated 2.8 quadrillion target-compound pairs.

◦Roche-Genentech and Bayer: We continue to advance our collaborations to discover potential new therapeutics with our strategic partners Roche-Genentech and Bayer. In the near-term, there is the potential for option exercises associated with partnership programs or option exercises associated with map building initiatives or data sharing.
•Platform
◦Digital Chemistry and Generative AI Capabilities: In May 2023, we acquired Cyclica and Valence Discovery to bolster our digital chemistry and generative AI capabilities and drive value across our pipeline, partnerships, and platform. Shortly after closing these acquisitions, we used Cyclica’s digital chemistry tools to predict the protein-ligand interactions for the over 1 million compounds in our internal, non-partnered chemical library. Now, less than one quarter after the closing of these acquisitions, we worked with our partners at NVIDIA to predict the protein-ligand interactions of approximately 36 billion compounds in the Enamine REAL Space, reported to be the world’s largest searchable chemical library.
◦Accelerating Pipeline and Partnership Value: For our internal pipeline, we have used our digital chemistry tools to deconvolve proteome-wide biological targets to confirm that certain compounds operate through a novel mechanism of action which was previously predicted by our functional phenomics maps. Such proteomic mapping capabilities provide an additional data layer to efficiently identify the most promising novel chemical series.
◦Foundation Model Construction: We continue to use our supercomputer, BioHive-1, to train a proprietary phenomics foundation model. As we have trained on larger quantities of our proprietary data, emergent properties have arisen out of the models and we have seen significant improvements over previous deep learning production models. We are also in the early stages of exploring more powerful and broadly useful foundation models based on our large-scale proprietary multi-omics data, which includes phenomics across 50 human cell types and approximately 1.7 million compounds, multi-timepoint live-cell microscopy, transcriptomics, proteomics, inVivomics, multi-target compound interactions, physicochemical properties, as well as predicted protein-ligand relationships. We may explore commercial licensing of some of our models in collaboration with NVIDIA and their BioNeMo platform in the coming year, though our state-of-the-art models will only be available to our team and close partners.
◦Large Language Models: One year ago, more than 40 employees were dedicated to exploring our maps of biology and chemistry to initiate programs at Recursion. Today, those same employees have been redeployed and our newest internal programs are being initiated autonomously. This efficiency and scale is through the deployment of large language models to map scientific literature in conjunction with our internally derived proprietary maps to identify opportunities for scientific arbitrage in areas of unmet need. These opportunities are then automatically prioritized for confirmation and validation in our highly-automated wetlabs. This is a significant step towards our vision of autonomous drug discovery and biological exploration.
◦Valence Labs – Powered by Recursion: In July 2023 at the International Conference for Machine Learning, we launched Valence Labs, Recursion’s cutting-edge machine learning research center for biology and chemistry in Montréal that aims to promote open-science and academic research. Recursion’s

commitment to open-science helps us recruit and retain the best talent in the field of generative AI, allows us to design and set the standards by which ML and AI are deployed in drug discovery, and may drive additional biopharma companies to consider partnering with Recursion to get access to our proprietary state-of-the-art tools, technology, datasets and programs.

Additional Corporate Updates
•Chief Medical Officer: In May 2023, David Mauro, M.D., Ph.D. joined Recursion as its Chief Medical Officer. Dr. Mauro has over 20 years experience in oncology drug development and has guided more than 25 Investigational New Drug candidates through the translational, preliminary and later stages of development at various companies.
•Chief Legal Officer: In July 2023, Recursion named Nathan Hatfield, J.D., M.B.A. as Chief Legal Officer. Mr. Hatfield has worked at Recursion for over 6 years, previously serving as SVP and Head of Legal. Prior to Recursion, Mr. Hatfield was a securities attorney at the law firm Wilson Sonsini Goodrich & Rosati.
•Toronto Office: In June 2023, we celebrated the opening of our Canadian Headquarters in Toronto with government officials as well as members of the technology and biotechnology communities.
•ESG Reporting: In June 2023, Recursion received a favorable ESG Risk Rating from Morningstar Sustainalytics which ranked Recursion as the #1 biotechnology company out of approximately 400 companies and the #14 pharmaceuticals company out of approximately 900 companies.

Second Quarter 2023 Financial Results

•Cash Position: Cash and cash equivalents were $405.9 million as of June 30, 2023. This cash position does not include the recent $50 million investment from NVIDIA.
•Revenue: Total revenue was $11.0 million for the second quarter of 2023, compared to $7.7 million for the second quarter of 2022. The increase was due to progress made in our Roche-Genentech collaboration.
•Research and Development Expenses: Research and development expenses were $55.1 million for the second quarter of 2023, compared to $38.4 million for the second quarter of 2022. The increase in research and development expenses was due to increased platform costs as we have expanded and upgraded our capabilities.
•General and Administrative Expenses: General and administrative expenses were $28.3 million for the second quarter of 2023, compared to $21.2 million for the second quarter of 2022. The increase in general and administrative expenses was due to an increase in salaries and wages of $3.0 million and increases in software and depreciation expense.
•Net Loss: Net loss was $76.7 million for the second quarter of 2023, compared to a net loss of $65.6 million for the second quarter of 2022.