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Takeda Announces FY2023 H1 Results; Updates Full-Year Forecasts While Remaining on Track Towards Management Guidance

On October 26, 2023 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the first half of fiscal year 2023 (six months ended September 30, 2023), updating reported and Core forecasts and reconfirming Management Guidance for Core change at CER (Press release, Takeda, OCT 26, 2023, View Source [SID1234636400]).

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Takeda chief executive officer, Christophe Weber, commented:
"We continue to pursue our vision to discover and deliver life-transforming treatments, making further progress in the first half of our fiscal year to address unmet medical needs and provide new treatment options to improve patient outcomes and quality of life. Our pipeline is robust and we anticipate a number of important milestones in the second half of the fiscal year, including potentially up to three new product approvals in the U.S., for TAK-755, fruquintinib, and TAK-721.

"Development setbacks with EXKIVITY and ALOFISEL, which impacted our reported profit in FY2023 Q2, highlight the inherent risk in research and development in the pharmaceutical business, but do not hinder our strategy for a return to growth in the near-term and our confidence in the long-term strength of the business remains firm."

Takeda chief financial officer, Costa Saroukos, commented:
"We are raising our full-year revenue and Core EPS forecasts to reflect updated foreign exchange and tax rate assumptions, while revising our reported operating profit and EPS forecasts to reflect large non-core items booked in our second quarter. These items do not reflect the underlying momentum of the business, and we remain on track to our Management Guidance, which is on a Core basis at CER.

"We continue to see strong performance of our Growth and Launch Products, which grew +13% at CER in the first half of the fiscal year and represent 42% of total revenue. While our Core revenue and profit performance in the first half continued to reflect the temporary headwinds we face this fiscal year, largely from generic competition, we believe our Growth and Launch Products will drive a return to revenue and profit growth in the near-term."

FINANCIAL HIGHLIGHTS

Results for FY2023 H1 Ended September 30, 2023

(Billion yen,
except
percentages and
per share
amounts)

REPORTED

CORE(c)

(Non-IFRS)(a)

FY2023 H1

vs. PRIOR YEAR

(Actual % change)

FY2023 H1

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change(d))

Revenue

2,101.7

+6.4%

2,101.7

+6.4%

+1.4%

Operating Profit

119.2

-53.2%

588.8

-5.8%

-9.5%

Margin

5.7%

-7.2pp

28.0%

-3.6pp

Net Profit

41.4

-75.2%

407.7

-8.7%

-13.8%

EPS (yen)

-75.4%

261

-9.4%

-14.4%

Operating Cash Flow

291.3

-4.6%

Free Cash Flow
(Non-IFRS)(a)(b)

-71.1

N/A

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source

(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.

(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, non-recurring items, purchase accounting effects and transaction related costs, as well as amortization and impairment of intangible assets and other operating income and expenses.

(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.

FY2023 OUTLOOK
Updating Full-Year FY2023 Reported and Core Forecasts, and Reconfirming Management Guidance

Based on Takeda’s first half results and reflecting expected foreign exchange rates during the second half of FY2023, Takeda’s reported and Core forecasts have been revised from the original forecast.

(Billion yen except per share amounts)

FY2023 ORIGINAL
FORECAST
(May 2023)

FY2023 REVISED
FORECAST
(October 2023)

FY2023 MANAGEMENT
GUIDANCE
Core Growth at CER
(Non-IFRS)
(Unchanged from May 2023)

Revenue

3,840.0

3,980.0

Core Revenue

3,840.0

3,980.0

Low-single-digit % decline

Reported Operating Profit

349.0

225.0

Core Operating Profit

1,015.0

Low-10s % decline

Reported Net Profit

142.0

93.0

Reported EPS (yen)

Core EPS (yen)

434

447

Low-20s % decline

Free Cash Flow*

400.0-500.0

Annual Dividend per Share (yen)

188

*Free Cash Flow forecast reflects expenditures related to the acquisition of TAK-279 from Nimbus (JPY134.1 billion) and in-licensing of fruquintinib from HUTCHMED (JPY55.1 billion).

Additional Information About Takeda’s H1 Earnings Results
For more details on Takeda’s FY2023 H1 results and other financial information, including key assumptions in FY2023 forecast and management guidance, please visit: View Source

For more information on Takeda’s commercial progress across the five key business areas and pipeline updates, please visit: View Source

Novocure Reports Third Quarter 2023 Financial Results

On October 26, 2023 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended September 30, 2023 (Press release, NovoCure, OCT 26, 2023, View Source [SID1234636399]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

"Primary data from our phase 3 LUNAR clinical trial were published in The Lancet Oncology; and multiple, post-hoc analyses were presented at major medical congresses, further illuminating the strength of the LUNAR clinical trial results. We look forward to completing the regulatory steps required to launch in our key markets."

"We are focused on extending survival in some of the most aggressive forms of cancer," said Asaf Danziger, Novocure’s Chief Executive Officer. "This quarter we continued our very successful launch in France and took significant strides in the rollout of our new arrays, which are thinner, lighter, and more flexible than our first-generation product. We are eager to build on this momentum as we prepare to treat significantly larger patient populations in the coming years."

"In Q3, we made considerable progress towards our goal of treating patients with non-small cell lung cancer," said William Doyle, Novocure’s Executive Chairman. "Primary data from our phase 3 LUNAR clinical trial were published in The Lancet Oncology; and multiple, post-hoc analyses were presented at major medical congresses, further illuminating the strength of the LUNAR clinical trial results. We look forward to completing the regulatory steps required to launch in our key markets."

Financial updates for the third quarter ended September 30, 2023:

Total net revenues for the quarter were $127.3 million, a decrease of 3% compared to the same period in 2022. The decrease resulted primarily from $14.5 million in reduced collections from denied or appealed claims in the U.S.
The United States, Germany and Japan contributed $86.2 million, $14.7 million and $7.6 million, respectively, with our other active markets contributing $12.1 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $6.8 million.
Gross margin for the quarter was 75%.
Research, development and clinical studies expenses for the quarter were $53.6 million, an increase of 3% from the same period in 2022. This primarily reflects the increase in quality assurance, regulatory affairs, product development and safety costs in anticipation of clinical trial launches and regulatory filings. Total clinical trial expenses can fluctuate quarter-to-quarter dependent upon the amount of clinical research organization services delivered, clinical materials procured and number of trials actively underway. As our current phase 3 clinical trials near completion, we expect to backfill our clinical trial pipeline with new phase 2 and 3 trials.
Sales and marketing expenses for the quarter were $58.0 million, an increase of 40% compared to the same period in 2022. This primarily reflects increased costs associated with geographic expansion and pre-launch activities intended to increase awareness of TTFields therapy in anticipation of future approvals in new indications.
General and administrative expenses for the quarter were $41.9 million, an increase of 29% compared to the same period in 2022. This primarily reflects increased personnel and project costs to support larger patient populations, new geographic launches, supply chain expansion and information technology enhancements.
Net loss for the quarter was $49.5 million with loss per share of $0.46.
Adjusted EBITDA* for the quarter was $(29.1) million.
Cash, cash equivalents and short-term investments were $921.2 million as of September 30, 2023.
Operational updates for the third quarter ended September 30, 2023:

1,467 prescriptions were received in the quarter, an increase of 6% compared to the same period in 2022. Prescriptions from the United States, Germany and Japan contributed 920, 163 and 85 prescriptions, respectively, with the remaining 299 prescriptions received in our other active markets.
As of September 30, 2023, there were 3,639 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,179, 492 and 353 active patients, respectively, with the remaining 615 active patients contributed by our other active markets.
Quarterly updates and achievements:

In August, the primary data from the phase 3 LUNAR clinical trial were published in The Lancet Oncology. These data were the basis for a CE Mark submission in June and will be submitted as part of a Premarket Approval submission to the U.S. Food and Drug Administration later this year.
In September, the first patient was enrolled in the phase 2 PANOVA-4 clinical trial evaluating the safety and efficacy of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel in the treatment of metastatic pancreatic cancer. The PANOVA-4 trial is the result of a clinical study collaboration with Roche.
In October, we entered an agreement with Stanford University to establish the Stanford School of Medicine Tumor Treating Fields Research Program, intended to support both preclinical and clinical trials exploring the use of TTFields.
In August, we announced the phase 3 INNOVATE-3 clinical trial for the treatment of platinum-resistant ovarian cancer did not meet the primary endpoint of overall survival at final analysis. An exploratory subgroup analysis suggested a potential survival benefit in patients who received only one prior line of therapy. Consistent with previously reported studies, TTFields therapy was well-tolerated with no added systemic toxicities. Full evaluation of the trial data, including subgroup analyses, is ongoing and we will work with trial investigators to share the full results with the scientific community in the future.
Anticipated clinical milestones:

Top-line data from phase 3 METIS clinical trial in brain metastases (Q1 2024)
Top-line data from phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (H2 2024)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2023 financial results at 8 a.m. EDT today, Thursday, October 26, 2023. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Personalis Launches NeXT Personal® Dx for Early Access Clinical Use in Residual Disease and Recurrence Detection in Cancer

On October 26, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer (Press release, Personalis, OCT 26, 2023, View Source [SID1234636398]). Designed to help oncologists detect cancer recurrence earlier and aid in treatment decision-making, NeXT Personal Dx is poised to reshape the clinical use of MRD testing by delivering unmatched sensitivity down to the level of one circulating tumor DNA (ctDNA) molecule in a million.

"Our ultra-sensitive NeXT Personal Dx test has the ability to reveal previously hidden traces of residual cancer, helping to reduce uncertainty for physicians and patients," said Chris Hall, President and CEO of Personalis. "We’re excited to work with oncologists through this Early Access Program to detect cancer even earlier and increase confidence in clinical decisions. We have several MDs that have expressed interest and we are already receiving samples."

NeXT Personal Dx features:

Unprecedented sensitivity and specificity: Industry-leading analytical sensitivity, detecting down to ~1 PPM (parts per million) or 1×10-6 tumor fraction and >99.9% analytical specificity
Whole genome-based tumor-informed assay: Selects up to 1,800 variants to design a highly sensitive and specific personalized tumor signature for each patient
NeXT SENSE technology: Proprietary Signal Enhancement and Noise Suppression Engine that, together with the personalized tumor signature, enables ultra-sensitive detection
The NeXT Personal Dx test is currently available through an Early Access Program to a limited number of clinical customers as the company builds clinical evidence and achieves Medicare reimbursement. The EAP will enable oncologists to access NeXT Personal Dx for clinical use, with a focus on lung cancer, breast cancer, and immunotherapy response monitoring.

Personalis also recently announced data from the groundbreaking TRACERx study investigating the use of NeXT Personal in early-stage lung cancer for MRD and recurrence detection. Personalis, along with collaborators from Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute, presented data at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress showing the ability of NeXT Personal to detect lung cancer more sensitively and identify cancer recurrence with a median lead time of approximately 6 to 11 months ahead of traditional imaging, and significantly longer than previous TRACERx results.

ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the 30th Annual Prostate Cancer Foundation Scientific Retreat

On October 26, 2023 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 30th Annual Prostate Cancer Foundation Scientific Retreat, taking place October 26-28, 2023, in Carlsbad, CA (Press release, ESSA, OCT 26, 2023, View Source [SID1234636397]). Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company’s website at www.essapharma.com.

"This poster, presented today at the Prostate Cancer Foundation Scientific Retreat, contains updated cohort 4 data from the dose escalation portion of our Phase 1/2 study evaluating the combination of masofaniten and enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC")," said David Parkinson, MD, President and CEO of ESSA. "While the data for patients in cohort four are still maturing, these updated data continue to demonstrate that the combination is well tolerated and leads to deep and durable reductions in prostate-specific antigen ("PSA"), including in cohort 4, which reflects the dosing regimen that is being evaluated in the Phase 2 dose expansion. We look forward to providing future updates."

Poster presentation details:

Title: Phase 1/2 Trial of Oral EPI-7386 (masofaniten) in Combination with Enzalutamide (Enz) Compared with Enz Alone in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC): Current Phase 1 (P1) results
Presenting Author: Andrew Laccetti, MD, MS, Memorial Sloan Kettering Cancer Center
Date and time: Thursday, October 26, 2023; 7:30-10:30 p.m. PT

Data summary: This Phase 1/2 multicenter, open-label clinical trial is enrolling patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today are from the first four cohorts of patients in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.

In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the doses tested through 21 cycles of dosing in some patients. Most frequent adverse events were Grade 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related.

In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). In the first three cohorts, 90% of patients (9 of 10) achieved PSA50 and PSA90, 80% of patients (8 of 10) achieved PSA90 in less than 90 days, and 70% of patients (7 of 10) achieved PSA <0.2mg/mL. Across all dose cohorts including patients in the recently enrolled cohort four, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 56% of patients (9 of 16) achieved PSA <0.2mg/mL. The randomized Phase 2 dose expansion portion of the study is currently enrolling.

About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten’s unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial (NCT05075577) in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

MEDIVIR AB – INTERIM REPORT JANUARY – SEPTEMBER 2023

On October 26, 2023 Medivir reported Updated data show that the combination fostrox + Lenvima provides improved clinical efficacy compared to Lenvima study data alone in second-line HCC (Press release, Medivir, OCT 26, 2023, View Source;interim-report-january–september-2023-301969891.html [SID1234636395]).

July – September

Financial summary for the quarter

Net turnover amounted to SEK 0.8 (1.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -23.4 (-13.9) million. Basic and diluted earnings per share amounted to SEK -0.42 (-0.27) and SEK -0.42 (-0.27) respectively.
Cash flow from operating activities amounted to SEK -21.0 (-19.7) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Significant events during the quarter

In August, Medivir’s Scientific Advisory Council was formed, consisting of five world-leading experts in liver cancer.
In August, the 15th patient was included in the phase 2a study with fostrox in combination with Lenvima. Interim data from an investigator evaluation showed promising tumor control and good tolerability.
In September, Medivir reported promising interim data from an independent evaluation of the phase 1b dose-escalation arm of fostrox in combination with Lenvima, where, among others, one patient achieved a complete tumor response and two patients a partial tumor response, out of a total of six patients.
In September, Medivir, together with leading cancer experts, arranged a webinar on the treatment landscape and the unique treatment challenges in primary liver cancer (HCC).
In September, data on the additive efficacy of fostrox in combination with Lenvima or Nexavar in non-clinical tumor models were presented at the ILCA Annual Meeting.
In September, Medivir’s partner Tango Therapeutics received IND approval from the FDA to start a phase 1/2 clinical trial with TNG348. TNG348 is a USP-1 inhibitor developed by Tango Therapeutics from the preclinical USP1 program that was in-licensed from Medivir in 2020.
January – September

Financial summary for the period

Net turnover amounted to SEK 3.2 (2.1) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -68.5 (-66.9) million. Basic and diluted earnings per share amounted to SEK -1.23 (-1.27) and SEK -1.23 (-1.27) respectively.
Cash flow from operating activities amounted to SEK -55.1 (-77.1) million.
Cash and cash equivalents at the end of the period amounted to SEK 61.1 (142.2) million.
Events after the end of the period

In October, data from the fostrox + Lenvima combination was presented, showing continued promising tumor control in HCC from an investigator evaluation. All patients in the phase 2a study had dosed at least two treatment cycles at this timepoint.
In October, the Board of Directors announced that Anette Lindqvist is leaving her position as Board Member of Medivir AB due to personal reasons.
In October the nomination committee was appointed ahead of the AGM in May 2024. The Nomination Committee consists of Karl Tobieson, appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB.
This Q3 report and subsequent webcast presents in-depth interim data from the 18 patients in the phase 1b/2a study who have had minimum 12 weeks follow-up. These data continue to demonstrate clear patient benefit for the fostrox + Lenvima combination.
Conference call for investors, analysts and the media

The Interim Report January – September 2023 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Friday, October 27, 2023, at 14.00 (CET).

To access the webcast and find information about the teleconference, please klick HERE!

The conference call will also be streamed via a link on the website: www.medivir.com/investors/calendar.

The presentation will be available on Medivir’s website after completion of the conference.