Ayala Pharmaceuticals Announces RINGSIDE Results to be Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 27, 2023 Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, reported that it will present a poster featuring data from the RINGSIDE study of AL102 at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place June 2-6, 2023 in Chicago, Illinois and virtually (Press release, Ayala Pharmaceuticals, APR 27, 2023, View Source [SID1234630591]).

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Details of the poster presentation are as follows:

Abstract Title: RINGSIDE phase 2/3 trial of AL102 for treatment of desmoid tumors (DT): Phase 2 results.
Presenter: Mrinal M. Gounder MD, Memorial Sloan Kettering Cancer Center
Abstract Number: 11515
Session Title: Sarcoma
Session Date and Time: Saturday, June 3, 2023, 5:30pm – 7:00pm EDT
Poster Display Time: 2:15pm – 5:15pm EST
In addition to the presentation of the study in the posters hall, Elizabeth J. Davis, MD of Vanderbilt University Medical Center, will highlight and discuss this and other selected abstracts in the Poster Discussion Session S404- Primary track: Sarcoma, on Saturday, June 3, 2023, 5:30pm EDT. The focus of this session will be on how the findings apply to clinical practice and future research. Dr. Davis and the abstract presenters will answer questions during a moderated panel discussion.

The ongoing Phase 2/3 RINGSIDE clinical trial is a randomized, global multi-center study evaluating AL102 in patients with progressing desmoid tumors. The study consists of two parts: Part A (Phase 2) is an open-label, dose regimen finding study; Part B (Phase 3) is a double blind, placebo-controlled study and Open Label Extension utilizing the dose regimen selected in Part A. The registration-enabling Phase 3 segment is enrolling patients globally. For more information on RINGSIDE, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall, or other parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to surgical morbidity and a high rate of recurrence post-surgery. There are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

About AL102

AL102 is an investigational small molecule Gamma Secretase Inhibitor (GSI) that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2/3 RINGSIDE clinical studies in patients with progressing desmoid tumors. AL102 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation. Ayala obtained an exclusive, worldwide license to develop and commercialize AL102 from Bristol-Myers Squibb Company in November 2017. AL102 was granted U.S. FDA Fast Track Designation for the treatment of DT.

Ascendis Pharma Reports First Quarter 2023 Financial Results

On April 27, 2023 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Ascendis Pharma, APR 27, 2023, View Source [SID1234630590]).

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"Based on our clinical experience with TransCon PTH to date, we have seen the improvement in the lives of many patients living with hypoparathyroidism and we are committed to working with regulatory authorities in the U.S. and EU to bring it to market as soon as possible," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We are managing our business to achieve our goal of reaching cash flow breakeven without the need for additional dilutive equity financing, supported by our first approved product, SKYTROFA, which is now accelerating to U.S. market value leadership. With advances across our portfolio and a focus on cost control, we remain on track to achieve Vision 3×3 to become a sustainable, profitable leading biopharma company."

Select Highlights & Anticipated 2023 Milestones

TransCon hGH:
First quarter 2023 SKYTROFA revenue grew to €31.6 million, including a negative foreign currency impact of €1.4 million compared to the previous quarter.
Q1-2022 Q2-2022 Q3-2022 Q4-2022 Q1-2023
SKYTROFA revenue (millions) €1.9 €4.4 €12.3 €17.1 €31.6

SKYTROFA commercial launch in Germany on track for the third quarter of 2023.
Expect topline results from Phase 3 foresiGHt trial in adult growth hormone deficiency in the fourth quarter of 2023.
TransCon PTH:
Committed to working with the FDA to address any NDA deficiencies.
145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years, and U.S. Expanded Access Program continues to enroll new patients.
Submitted application to initiate an early access program in Germany during the second quarter of 2023. If approved, expect to enroll first patient during the second quarter of 2023.
Anticipate European Commission decision on MAA during the fourth quarter of 2023. If approved, first launch planned in Germany in early 2024.
TransCon CNP:
As of March 31, 2023, all 57 patients remain in the open-label extension (OLE) portion of the Phase 2 ACcomplisH trial with treatment duration up to 3 years. One-year follow-up data from OLE expected in the fourth quarter of 2023.
Expect to complete target enrollment of ~80 patients in ApproaCH, a global randomized, double-blind, placebo-controlled Phase 2b trial in children ages 2–11 years with achondroplasia, during the second quarter of 2023.
TransCon TLR7/8 Agonist:
Enrollment in the dose expansion portion of the Phase 1/2 transcendIT-101 trial continues, with a focus on investigating TransCon TLR7/8 Agonist in combination with pembrolizumab in four different cancer types.
TransCon IL-2 β/γ
Initial monotherapy dose escalation data from the ongoing Phase 1/2 IL-Believe trial of TransCon IL-2 β/γ alone or in combination with pembrolizumab will be published online at ASCO (Free ASCO Whitepaper) 2023. Dose escalation combination therapy results expected during the third quarter of 2023.
Preparing to initiate Believe-IT-201, a randomized Phase 2 trial of TransCon IL-2 β/γ and TLR7/8 combination therapies, in the second quarter of 2023.
Ended the first quarter of 2023 with cash, cash equivalents, and marketable securities totaling €585.7 million.
First Quarter 2023 Financial Results

Total revenue for the first quarter of 2023 was €33.6 million compared to €6.8 million during the same period in 2022. The increase was primarily attributable to higher SKYTROFA revenue of €31.6 million compared to €1.9 million in the same period last year.

Research and development (R&D) costs for the first quarter were €106.1 million compared to €83.2 million during the same period in 2022. This increase was primarily due to higher development costs for Ascendis Pharma oncology programs, TransCon IL-2 β/γ and TransCon TLR7/8, reflecting the advancement of these product candidates.

Selling, general, and administrative (SG&A) expenses for the first quarter were €66.5 million compared to €47.4 million during the same period in 2022. This increase was primarily due to higher external commercial expenses related to SKYTROFA and to pre-launch activities for TransCon PTH, higher employee related expenses, and an increase in other general and administrative expenses attributable to organizational growth.

Net finance income was €35.3 million in the first quarter compared to €7.6 million in the same period in 2022.

For the first quarter of 2023, Ascendis Pharma reported a net loss of €110.9 million, or €1.98 per share (basic and diluted) compared to a net loss of €125.5 million, or €2.21 per share (basic and diluted) for the same period in 2022.

As of March 31, 2023, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €585.7 million compared to €742.9 million as of December 31, 2022. As of March 31, 2023, Ascendis Pharma had 57,328,548 ordinary shares outstanding.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its first quarter 2023 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.

AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS

On April 27, 2023 Amgen (NASDAQ:AMGN) reported its financial results for the first quarter of 2023 (Press release, Amgen, APR 27, 2023, View Source [SID1234630586]).

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"We delivered 14% volume growth driven by the breadth of our portfolio and strong demand for our products globally," said Robert A. Bradway, chairman and chief executive officer. "We look forward to closing the acquisition of Horizon Therapeutics and joining forces to reach more patients around the world with their innovative medicines."

Key results include:

Total revenues decreased 2% to $6.1 billion in comparison to the first quarter of 2022, resulting from lower Other Revenue from our COVID-19 manufacturing collaboration, partially offset by a 2% increase in product sales. Product sales growth was driven by 14% volume growth, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange. Excluding the 2% negative impact of foreign exchange on product sales, total revenues were largely unchanged from Q1 2022.
Volume growth of 14% included double-digit volume growth from EVENITY (romosozumab-aqqg), BLINCYTO (blinatumomab), Nplate (romiplostim), LUMAKRAS/LUMYKRAS (sotorasib), AMJEVITA/AMGEVITA (adalimumab), Repatha (evolocumab), KYPROLIS (carfilzomib) and Vectibix (panitumumab).
Ex-U.S. volume grew 22%, including 47% volume growth in the Asia Pacific region.
GAAP earnings per share (EPS) increased 97% from $2.68 to $5.28, driven by other income due to a mark-to-market gain on our investment in BeiGene, Ltd. and lower weighted-average shares outstanding in Q1 2023.
GAAP operating income decreased from $2.5 billion to $1.9 billion, and GAAP operating margin decreased 10.7 percentage points to 32.9%.
Non-GAAP EPS decreased 6% from $4.25 to $3.98, driven by decreased revenues and higher operating expenses, primarily related to research & development, in Q1 2023.
Non-GAAP operating income decreased from $3.1 billion to $2.8 billion, and non-GAAP operating margin decreased 6.5 percentage points to 48.3%.
The Company generated $0.7 billion of free cash flow for the first quarter of 2023 versus $2.0 billion in the first quarter of 2022, driven by the timing of payments for sales incentives, rebates and discounts, lower operating income, and higher capital expenditures from the build-out of our new North Carolina and Ohio facilities.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow) and "total revenues and product sales adjusted for foreign exchange impact" (computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

Total product sales increased 2% for the first quarter of 2023 versus the first quarter of 2022. Unit volumes grew 14%, partially offset by 5% lower net selling price, 3% unfavorable changes to estimated sales deductions, 2% lower inventory levels and 2% negative impact from foreign exchange.

General Medicine

Repatha sales increased 18% year-over-year to a record $388 million for the first quarter. Volume growth of 33% for the quarter was partially offset by lower net selling price. In the U.S., sales grew 19%, driven by 32% volume growth, partially offset by lower net selling price and inventory levels. Outside the U.S., sales grew 16%, driven by 34% volume growth, partially offset by lower net selling price and unfavorable foreign exchange impact. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, with over 1.7 million patients treated since launch.

Prolia (denosumab) sales increased 9% year-over-year for the first quarter, driven by 8% volume growth.

EVENITY sales increased 49% year-over-year to a record $254 million for the first quarter, primarily driven by strong volume growth across our markets. U.S. volumes grew 43% year-over-year and volumes outside the U.S. grew 77%.

Aimovig (erenumab-aooe) sales decreased 32% year-over-year for the first quarter, driven by unfavorable changes to estimated sales deductions and lower net selling price. For 2023, we expect continued year-over-year net selling price declines in order to maintain broad formulary access for patients in response to competitive dynamics.
Inflammation

TEZSPIRE (tezepelumab-ekko) generated $96 million of sales in the first quarter, driven by strong adoption in the U.S. by both allergists and pulmonologists. Quarter-over-quarter sales increased 22%, driven by volume growth. Healthcare providers appreciate TEZSPIRE’s unique, differentiated profile and its broad potential to treat the 2.5 million patients worldwide with severe asthma who are uncontrolled, without any phenotypic or biomarker limitation. During the first quarter, the U.S. Food and Drug Administration (FDA) approved TEZSPIRE for self-administration in a pre-filled, single-use pen, which improves accessibility and provides more flexibility in treatment options for patients in the U.S.

TAVNEOS (avacopan) generated $23 million of sales in the first quarter. Quarter-over-quarter sales increased 10%, driven by higher net selling price and inventory levels, partially offset by lower ex-U.S. volume driven by the timing of shipments to our ex-U.S. partner in the fourth quarter of 2022. U.S volume grew 27% quarter-over-quarter, driven by an increase in new patients starting treatment.

Otezla (apremilast) sales decreased 13% year-over-year for the first quarter, driven by lower inventory levels and net selling price, partially offset by 5% volume growth. Otezla followed the historical pattern of lower first quarter sales relative to the remainder of the year due to the impact of benefit plan changes, insurance reverifications and increased co-pay expenses as U.S. patients worked through deductibles. U.S. sales in the first quarter were also impacted by lower specialty pharmacy inventory levels compared to previous years, and price declines resulting from patient mix and additional rebates to improve the quality of coverage. In the U.S., Otezla new patient demand was impacted by free drug programs for newly launched topical and systemic competitors. We expect new patient demand to continue to be impacted by free drug programs from newly launched competition throughout 2023.

We continue to see strong growth potential for Otezla given its established efficacy and safety profile, strong payor coverage with limited prior authorization requirements and ease of administration. Otezla remains the only approved oral systemic therapy with a broad indication and is well-positioned to help the 1.5 million U.S. patients with mild-to-moderate psoriasis that cannot be optimally addressed by a topical and can benefit from a systemic treatment like Otezla.

Enbrel (etanercept) sales decreased 33% year-over-year for the first quarter, driven by decline in net selling price, lower inventory levels in the distribution channel compared to previous years and a 9% unfavorable impact of changes to estimated sales deductions related to prior periods. Consistent with Otezla, sales in the first quarter were also impacted by typical patterns of benefit plan changes and higher co-pay expenses. Year-over-year volume was flat in the first quarter, with U.S. volume growing 1%, supported by improved payor coverage. For the remainder of 2023, we expect low single-digit volume growth, reduced year-over-year decline in net selling price and a gradual recovery in inventory levels.

AMJEVITA/AMGEVITA sales increased 52% year-over-year to a record $164 million for the first quarter, driven by higher inventory levels and 35% volume growth, partially offset by unfavorable foreign exchange impact. AMJEVITA launched in the U.S. early in the first quarter, and a majority of U.S. sales in the quarter were related to inventory build.
Hematology-Oncology

BLINCYTO sales increased 41% year-over-year to a record $194 million for the first quarter, driven by 49% volume growth supported by strong adoption across academic and community centers.

Vectibix sales increased 16% year-over-year for the first quarter, driven by 15% volume growth supported by positive data from the Phase 3 PARADIGM trial demonstrating the superiority of Vectibix over bevacizumab in combination with chemotherapy.

KYPROLIS sales increased 25% year-over-year to a record $358 million for the first quarter, driven by 18% volume growth, higher net selling price and strong global execution.

LUMAKRAS/LUMYKRAS generated $74 million of sales for the first quarter. Year-over-year sales increased 19% for the first quarter, driven by 40% volume growth, partially offset by lower net selling price. Outside the U.S., LUMYKRAS has been approved in 50 countries around the world. We are actively launching in over 30 markets and pursuing reimbursement in the remaining countries.

XGEVA (denosumab) sales increased 7% year-over-year for the first quarter, driven by higher net selling price and 4% volume growth.

Nplate sales increased 36% year-over-year for the first quarter, driven by 41% volume growth. Nplate sales in the first quarter included $82 million related to an order from the U.S. government.

MVASI (bevacizumab-awwb) sales decreased 17% year-over-year for the first quarter, driven by lower net selling price, partially offset by 15% volume growth. The published first quarter Average Selling Price (ASP) for MVASI in the U.S. declined 27% year-over-year and increased 5% quarter-over-quarter. Going forward, we expect continued net selling price erosion driven by increased competition.

KANJINTI (trastuzumab-anns) sales decreased 51% year-over-year for the first quarter, driven by lower net selling price and volume. The published first quarter ASP for KANJINTI in the U.S. declined 36% year-over-year and increased 3% quarter-over-quarter. Going forward, we expect continued net selling price erosion and declining volume driven by increased competition.
Established Products

Total sales of our established products, which include EPOGEN (epoetin alfa), Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide), and Neulasta (pegfilgrastim), decreased 17% year-over-year for the first quarter, driven by lower net selling price, unfavorable changes to estimated sales deductions, and lower volume. The published first quarter ASP for Neulasta in the U.S. declined 26% year-over-year and increased 3% quarter-over-quarter. In the aggregate, we expect the year-over-year net selling price and volume erosion for this portfolio of products to continue.

Product Sales Detail by Product and Geographic Region

$Millions, except percentages


Q1 ’23


Q1 ’22


YOY Δ


US


ROW


TOTAL


TOTAL


TOTAL

Repatha


197


191


388


329


18 %

Prolia


623


304


927


852


9 %

EVENITY


164


90


254


170


49 %

Aimovig


64


5


69


101


(32 %)

TEZSPIRE


96



96


7


*

TAVNEOS


23



23



NM

Otezla


294


98


392


451


(13 %)

Enbrel


564


15


579


862


(33 %)

AMJEVITA/AMGEVITA


51


113


164


108


52 %

BLINCYTO


126


68


194


138


41 %

Vectibix


111


122


233


201


16 %

KYPROLIS


234


124


358


287


25 %

LUMAKRAS/LUMYKRAS


48


26


74


62


19 %

XGEVA


384


152


536


502


7 %

Nplate


246


116


362


266


36 %

MVASI


121


81


202


244


(17 %)

KANJINTI


33


14


47


96


(51 %)

EPOGEN


60



60


120


(50 %)

Aranesp


115


240


355


358


(1 %)

Parsabiv


58


33


91


86


6 %

Neulasta


211


38


249


348


(28 %)

Other products**


152


41


193


143


35 %

Total product sales


$ 3,975


$ 1,871


$ 5,846


$ 5,731


2 %


*Change in excess of 100%


** Other products include Corlanor, AVSOLA, NEUPOGEN, RIABNI, IMLYGIC and Sensipar/Mimpara, as well as sales by Bergamo and GENSENTA subsidiaries.

NM = not meaningful

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 12%. Cost of Sales margin increased 2.2 percentage points, primarily driven by amortization of intangible assets from acquisitions, asset-related impairments, changes in product mix, and higher profit share. Research & Development (R&D) expenses increased 10%, primarily due to higher investments in late-stage programs, research and the early pipeline, and marketed product support. Selling, General & Administrative (SG&A) expenses increased 2%.
Operating Margin as a percentage of product sales decreased 10.7 percentage points to 32.9%.
Tax Rate increased 5.6 percentage points, primarily driven by the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 and an increase in the interest expense on tax reserves.
On a non-GAAP basis:

Total Operating Expenses increased 6%. Cost of Sales margin increased 0.8 percentage points, primarily driven by changes in product mix and higher profit share. R&D expenses increased 12%, due to higher investments in late-stage programs, research and the early pipeline, and marketed product support. SG&A expenses increased 1%.
Operating Margin as a percentage of product sales decreased 6.5 percentage points in the first quarter to 48.3%.
Tax Rate increased 3.7 percentage points, primarily due to the 2022 Puerto Rico tax law change that replaced the excise tax with an income tax beginning in 2023 and an increase in the interest expense on tax reserves.

$Millions, except percentages


GAAP


Non-GAAP


Q1 ’23


Q1 ’22


YOY Δ


Q1 ’23


Q1 ’22


YOY Δ

Cost of Sales


$ 1,720


$ 1,561


10 %


$ 1,016


$ 951


7 %

% of product sales


29.4 %


27.2 %


2.2 pts


17.4 %


16.6 %


0.8 pts

Research & Development


$ 1,058


$ 959


10 %


$ 1,044


$ 934


12 %

% of product sales


18.1 %


16.7 %


1.4 pts


17.9 %


16.3 %


1.6 pts

Selling, General & Administrative


$ 1,258


$ 1,228


2 %


$ 1,224


$ 1,213


1 %

% of product sales


21.5 %


21.4 %


0.1 pts


20.9 %


21.2 %


(0.3) pts

Other


$ 148


$ (10)


*


$ —


$ —


NM

Total Operating Expenses


$ 4,184


$ 3,738


12 %


$ 3,284


$ 3,098


6 %


Operating Margin


operating income as % of product sales


32.9 %


43.6 %


(10.7) pts


48.3 %


54.8 %


(6.5) pts


Tax Rate


17.5 %


11.9 %


5.6 pts


17.8 %


14.1 %


3.7 pts


pts: percentage points


* change in excess of 100%


NM = not meaningful


Cash Flow and Balance Sheet

The Company generated $0.7 billion of free cash flow in the first quarter of 2023 versus $2.0 billion in the first quarter of 2022, driven by the timing of payments for sales incentives, rebates and discounts, lower operating income, and higher capital expenditures from the build-out of our new North Carolina and Ohio facilities.
The Company’s first quarter 2023 dividend of $2.13 per share was declared on December 12, 2022, and was paid on March 8, 2023, to all stockholders of record as of February 15, 2023, representing a 10% increase from 2022.
During the first quarter, there were no repurchases of common stock.
Cash and investments totaled $31.6 billion and debt outstanding totaled $61.6 billion as of March 31, 2023.

$Billions, except shares


Q1 ’23


Q1 ’22


YOY Δ

Operating Cash Flow


$ 1.1


$ 2.2


$ (1.1)

Capital Expenditures


$ 0.3


$ 0.2


$ 0.2

Free Cash Flow


$ 0.7


$ 2.0


$ (1.3)

Dividends Paid


$ 1.1


$ 1.1


$ 0.1

Share Repurchases


$ —


$ 6.3


$ (6.3)

Average Diluted Shares (millions)


538


551


(13)


Note: Numbers may not add due to rounding

$Billions


3/31/23


12/31/22


YTD Δ

Cash and Investments


$ 31.6


$ 9.3


$ 22.3

Debt Outstanding


$ 61.6


$ 38.9


$ 22.7


Note: Numbers may not add due to rounding

2023 Guidance (Excludes any contribution from the announced acquisition of Horizon Therapeutics plc)

The Company expects the announced acquisition of Horizon Therapeutics plc (Horizon) to close in the first half of 2023. For the full year 2023, excluding any contribution from the announced acquisition of Horizon, the Company now expects:

Total revenues in the range of $26.2 billion to $27.3 billion.
On a GAAP basis, EPS in the range of $15.38 to $16.59, and a tax rate in the range of 17.0% to 18.5%.
On a non-GAAP basis, EPS in the range of $17.60 to $18.70, and a tax rate in the range of 18.0% to 19.0%.
Capital expenditures to be approximately $925 million.
Share repurchases not to exceed $500 million.
First Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

General Medicine

Olpasiran (AMG 890)

A Phase 3 cardiovascular outcomes study of olpasiran, a small interfering RNA molecule that reduces Lp(a) synthesis in the liver, in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a) (Lp(a)), continues to enroll.
In March, a new analysis from the OCEAN(a) Phase 2 Dose study was presented at the American College of Cardiology’s 72nd Annual Scientific Session, together with World Heart Federation’s World Congress of Cardiology. This analysis demonstrated that olpasiran treatment resulted in a placebo-adjusted percentage reduction in Lp(a) of > 95% when dosed 75 mg or higher every 12 weeks irrespective of baseline Lp(a) level in individuals with ASCVD and Lp(a) > 150 nmol/L.
In February, the Company announced the initiation of the African American Heart Study, in collaboration with the Association of Black Cardiologists and the Morehouse School of Medicine. This study will measure the association between Lp(a) and ASCVD in 5,000 African American individuals to better understand the association between Lp(a) levels and incident ASCVD in persons of African American descent.
AMG 133

A Phase 2 study of AMG 133, a multispecific molecule that inhibits the gastric inhibitory polypeptide receptor (GIPR) and activates the glucagon like peptide 1 (GLP 1) receptor, in overweight or obese adults, with or without type 2 diabetes mellitus, continues to enroll.
AMG 786

A small-molecule obesity program continues to enroll patients in a Phase 1 study. This molecule has a different target than AMG 133 and is not an incretin-based therapy.
Repatha

In March, analyses from the Repatha FOURIER and FOURIER open-label extension studies were presented at the American College of Cardiology’s 72nd Annual Scientific Session, together with World Heart Federation’s World Congress of Cardiology, demonstrating that earlier initiation with Repatha was associated with a reduced number of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, unstable angina, or coronary revascularization.
EVOLVE-MI, a Phase 4 study of Repatha administered very early to reduce the risk of cardiovascular events in patients hospitalized with acute myocardial infarction, continues to enroll patients.
Prolia

In May, the Company will present results of the largest head-to-head, real-world study in postmenopausal osteoporosis, comparing fracture risk reduction of Prolia with bisphosphonates at the European Society for Clinical and Economic Aspects of Osteoporosis meeting.
Aimovig

A randomized, double-blind, placebo-controlled Phase 4 trial investigating the efficacy and safety of Aimovig in patients with chronic migraine and medication overuse headache (MOH) met its primary endpoint (absence of MOH at month 6) in the 140 mg dose group. This group also experienced statistically significant improvements on the secondary endpoints of change from baseline in acute headache medication days and sustained MOH remission. Other secondary endpoints were consistent in favoring the Aimovig-treated groups; however, they did not achieve statistical significance with the testing methodology applied. There were no new safety signals observed in the study, and the overall safety profile was consistent with what has been described.
Inflammation

TEZSPIRE

In February, the FDA approved TEZSPIRE for self-administration in a prefilled, single-use pen for patients aged 12 years and older with severe asthma.
In severe asthma, the PASSAGE Phase 4 real-world effectiveness study, the WAYFINDER Phase 3b study and the SUNRISE Phase 3 study continue to enroll patients.
A Phase 3 study of TEZSPIRE in chronic rhinosinusitis with nasal polyps continues to enroll patients.
A Phase 3 study of TEZSPIRE in eosinophilic esophagitis has begun enrolling patients.
A Phase 2b study of TEZSPIRE in chronic spontaneous urticaria is complete, with top-line data anticipated in mid-2023.
A Phase 2 study of TEZSPIRE in chronic obstructive pulmonary disease is fully enrolled. Data read out is anticipated in H1 2024.
Rocatinlimab (AMG 451 / KHK4083)

The ROCKET Phase 3 program, composed of seven studies evaluating rocatinlimab, an anti-OX40 monoclonal antibody, is enrolling adult and adolescent patients with moderate to severe atopic dermatitis.
Rozibafusp alfa (AMG 570)

A Phase 2b study of rozibafusp alfa, an antibody-peptide conjugate that simultaneously blocks inducible T-cell costimulatory ligand (ICOSL) and B-cell activating factor (BAFF) activity, in systemic lupus erythematosus (SLE), was stopped for futility.
Efavaleukin alfa (AMG 592)

A Phase 2b study of efavaleukin alfa, an interleukin-2 (IL-2) mutein Fc fusion protein, in SLE was stopped for futility.
A Phase 2b study of efavaleukin alfa in ulcerative colitis continues to enroll patients.
Ordesekimab (AMG 714 / PRV-015)

A Phase 2b study of AMG 714, a monoclonal antibody that binds interleukin-15, in nonresponsive celiac disease continues to enroll patients.
Oncology

BLINCYTO

Global regulatory authority submissions are planned in H2 2023 for E1910, a Phase 3 trial conducted by the National Cancer Institute, the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG ACRIN) Cancer Research Group that demonstrated superior overall survival with BLINCYTO treatment added to consolidation chemotherapy over standard of care consolidation chemotherapy in newly diagnosed adult patients with Philadelphia chromosome negative B-cell acute lymphoblastic leukemia (ALL) who were measurable residual disease (MRD) negative following induction and intensification chemotherapy.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome negative B-cell ALL, continues to enroll patients.
A Phase 1/2 study of subcutaneous BLINCYTO in adults with relapsed or refractory Philadelphia chromosome negative B-cell ALL continues to enroll patients.
Tarlatamab (AMG 757)

DeLLphi-304, a Phase 3 study comparing tarlatamab, a half-life extended BiTE molecule targeting delta-like ligand 3, with standard of care chemotherapy in second-line small-cell lung cancer (SCLC), will be initiated this month.
DeLLphi-301, a potentially registrational Phase 2 study of tarlatamab being studied in heavily pretreated patients with SCLC, continues to enroll patients. Data readout is anticipated in H2 2023.
DeLLphi-300, a Phase 1 study of tarlatamab in relapsed/refractory SCLC, continues to enroll patients.
DeLLphi-302, a Phase 1b study of tarlatamab in combination with AMG 404, an anti-programmed cell death-1 monoclonal antibody, in second-line or later SCLC, is ongoing.
DeLLphi-303, a Phase 1b study of tarlatamab in combination with standard-of-care in first-line SCLC, continues to enroll patients.
DeLLpro-300, a Phase 1b study of tarlatamab, in de novo or treatment-emergent neuroendocrine prostate cancer, continues to enroll patients.
Bemarituzumab

FORTITUDE-101, a Phase 3 study of bemarituzumab, a fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody, plus chemotherapy in first-line gastric cancer, continues to enroll patients.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer, continues to enroll patients in the Phase 3 portion of the study.
FORTITUDE-103, a Phase 1b study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab in first-line gastric cancer, continues to enroll patients.
FORTITUDE-201, a Phase 1b study of bemarituzumab monotherapy and in combination with standard-of-care therapy, in squamous non-small cell lung cancer (NSCLC) with FGFR2b overexpression, continues to enroll patients.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression, continues to enroll patients in the Phase 2 portion of the study.
LUMAKRAS/LUMYKRAS

The Company continues to investigate novel combinations and is advancing a comprehensive global clinical development program in NSCLC, colorectal cancer (CRC), and other solid tumors to further explore the potential of LUMAKRAS.
A Phase 3 study of LUMAKRAS in combination with Vectibix in third-line CRC is fully enrolled. Data readout is anticipated in H2 2023.
Combination study data of LUMAKRAS in combination with standard of care chemotherapy in NSCLC and LUMAKRAS in combination with Vectibix and standard of care chemotherapy in CRC will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
In March, the Company completed submission of the LUMAKRAS CodeBreak 200 Phase 3 confirmatory data, along with data from the Phase 2 dose comparison substudy, to the FDA and to the European Medicines Agency (EMA).
In February, results from a Phase 3 multicenter, randomized, open label, active-controlled, study of LUMAKRAS versus docetaxel for the treatment of previously treated locally advanced and unresectable or metastatic NSCLC subjects with mutated KRAS G12C (CodeBreak 200) were published in The Lancet.
Xaluritamig (formerly AMG 509)

A Phase 1 dose-escalation/expansion study of xaluritamig, a bispecific molecule targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1) in metastatic castrate-resistant prostate cancer (mCRPC), continues to enroll patients. Initial data readout is anticipated in H2 2023.
AMG 340

A Phase 1 dose-escalation study of AMG 340, a lower T-cell affinity BiTE molecule targeting prostate-specific membrane antigen (PSMA), in mCRPC, continues to enroll patients.
AMG 193

A Phase 1/1b/2 study of AMG 193, a small-molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, continues to enroll patients with advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
Biosimilars

In April 2023, the European Commission (EC) granted marketing authorization for BEKEMV (eculizumab, formerly ABP 959), a biosimilar to SOLIRIS (eculizumab). BEKEMV is the first biosimilar to SOLIRIS approved by the EC. BEKEMV is approved only for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening bone marrow disorder. In February, the Company submitted the U.S. Biologics License Application to the FDA for this molecule.
A Phase 3 switching study to support an interchangeability designation in the U.S. for AMJEVITA, using an investigational high-concentration formulation of AMJEVITA (ABP 501, 100 mg/mL) evaluating multiple switches between Humira (adalimumab) and AMJEVITA compared with continued use of Humira, met its primary endpoint of similarity for the primary pharmacokinetics (PK) endpoints, based on a prespecified PK similarity range.
A Phase 3 switching study to support an interchangeability designation in the U.S. for ABP 654, an investigational biosimilar to STELARA (ustekinumab), is ongoing. Data readout is anticipated in H1 2023.
The final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA (aflibercept) compared with EYLEA in patients with neovascular age-related macular degeneration, is expected in H1 2023.
TEZSPIRE is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451 / KHK4083 is being developed in collaboration with Kyowa Kirin.
Ordesekimab formerly AMG 714 and also known as PRV-015 is being developed in collaboration with Provention Bio.
AMG 509 is being developed in collaboration with Xencor.
Humira is a registered trademark of AbbVie, Inc.
STELARA is a registered trademark of Janssen Pharmaceutica NV.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the first quarters of 2023 and 2022, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2023 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Beginning January 1, 2022, following industry guidance from the U.S. Securities and Exchange Commission, the Company no longer excludes adjustments for upfront license fees, development milestones and in-process research and development (IPR&D) expenses of pre-approval programs related to licensing, collaboration and asset acquisition transactions from its non-GAAP financial measures. GAAP financial measures are included in the news release. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarter of 2023 and 2022. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Total Revenues and Product Sales Adjusted for Foreign Exchange Impact, which is a non-GAAP financial measure, for the first quarter of 2023. Total Revenues and Product Sales Adjusted for Foreign Exchange Impact is computed by converting our current period local currency product sales using the prior period foreign exchange rates and comparing that to our current period product sales.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity. The Company believes Total Revenues and Product Sales Adjusted for Foreign Exchange Impact provides supplementary information on the Company’s product sales performance by excluding changes in foreign exchange rates between comparative periods.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

AbbVie Reports First-Quarter 2023 Financial Results

On April 27, 2023 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2023 (Press release, AbbVie, APR 27, 2023, View Source [SID1234630585]).

"This year is off to an excellent start, with first-quarter revenues and EPS ahead of our expectations, driven by strong commercial execution across all areas of our diversified portfolio," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "These balanced results give us confidence to increase our full-year guidance and we see numerous opportunities for key assets to drive compelling long-term growth."

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Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates. 1

First-Quarter Results

•Worldwide net revenues were $12.225 billion, a decrease of 9.7 percent on a reported basis, or 8.3 percent on an operational basis.

•Global net revenues from the immunology portfolio were $5.587 billion, a decrease of 9.0 percent on a reported basis, or 7.8 percent on an operational basis.
◦Global Humira net revenues of $3.541 billion decreased 25.2 percent on a reported basis, or 24.3 percent on an operational basis. U.S. Humira net revenues were $2.948 billion, a decrease of 26.1 percent. Internationally, Humira net revenues were $593 million, a decrease of 20.3 percent on a reported basis, or 14.8 percent on an operational basis.
◦Global Skyrizi net revenues were $1.360 billion, an increase of 44.7 percent on a reported basis, or 46.3 percent on an operational basis.
◦Global Rinvoq net revenues were $686 million, an increase of 47.5 percent on a reported basis, or 51.2 percent on an operational basis.

•Global net revenues from the hematologic oncology portfolio were $1.416 billion, a decrease of 14.0 percent on a reported basis, or 12.9 percent on an operational basis.
◦Global Imbruvica net revenues were $878 million, a decrease of 25.2 percent, with U.S. net revenues of $638 million and international profit sharing of $240 million.
◦Global Venclexta net revenues were $538 million, an increase of 13.7 percent on a reported basis, or 17.5 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $1.695 billion, an increase of 13.9 percent on a reported basis, or 15.0 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $719 million, an increase of 17.1 percent on a reported basis, or 18.7 percent on an operational basis.
◦Global Vraylar net revenues were $561 million, an increase of 31.3 percent.
◦Global Ubrelvy net revenues were $152 million, an increase of 10.0 percent.

•Global net revenues from the aesthetics portfolio were $1.300 billion, a decrease of 5.4 percent on a reported basis, or 2.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $659 million, an increase of 2.9 percent on a reported basis, or 5.8 percent on an operational basis.
◦Global Juvederm net revenues were $355 million, a decrease of 13.4 percent on a reported basis, or 7.4 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the first quarter was 67.4 percent. The adjusted gross margin ratio was 84.2 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 24.9 percent of net revenues. The adjusted SG&A expense was 24.4 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 18.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

•Acquired IPR&D and milestones expense was 1.2 percent of net revenues.

•On a GAAP basis, the operating margin in the first quarter was 22.6 percent. The adjusted operating margin was 45.0 percent.

•Net interest expense was $454 million.

•On a GAAP basis, the tax rate in the quarter was 49.3 percent. The adjusted tax rate was 13.7 percent.

•Diluted EPS in the first quarter was $0.13 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
2

Recent Events

•AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg induction dose, 15 mg and 30 mg maintenance doses) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The approval is based on results from three studies in which Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This is the seventh approved indication for Rinvoq in the European Union (EU).

•AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint of clinical remission at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis (UC). Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced positive top-line results from a Phase 2 study of Rinvoq (30 mg, once daily), given alone or as combination therapy (ABBV-599) with a Bruton’s Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE). The study met the primary endpoint of SLE Responder Index (SRI-4) with a steroid dose of less than or equal to 10 mg per day at week 24 in patients with moderately to severely active SLE. Based on these results, AbbVie intends to advance its clinical program of Rinvoq in SLE to Phase 3.

•At the Congress of European Crohn’s and Colitis Organisation (ECCO), AbbVie presented 24 abstracts, including four oral presentations, two digital oral presentations and 18 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio. Highlights included data from the ADVANCE, MOTIVATE and FORTIFY studies highlighting efficacy outcomes and clinical response in patients receiving Skyrizi for treatment of moderately to severely active CD, sub-analyses from the U-EXCEL, U-EXCEED and U-ENDURE studies evaluating Rinvoq for the treatment of moderately to severely active CD and analyses evaluating Rinvoq for the treatment of UC.

•At the 2023 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented more than 20 abstracts showcasing the strength of its dermatology portfolio. Notable presentations included late-breaking data that demonstrated Skyrizi improved plaque psoriasis (PsO) signs and symptoms among moderate to severe PsO patients that previously had a suboptimal response to IL-17 inhibitor therapy; abstracts assessing long-term outcomes of Skyrizi in patients with active psoriatic arthritis (PsA); subgroup analyses of outcomes in adults and adolescents with atopic dermatitis (AD) from three Phase 3 trials assessing the efficacy and safety of Rinvoq across 52 weeks; and results from a Phase 2 study evaluating the efficacy and safety of Rinvoq in moderate-to-severe hidradenitis suppurativa (HS).

•AbbVie announced that it intends to voluntarily withdraw the U.S. accelerated Imbruvica (ibrutinib) approvals for patients with mantle cell lymphoma (MCL) who received at least one prior therapy and patients with marginal zone lymphoma (MZL) who require systemic therapy and received at least one prior anti-CD20-based therapy. This voluntary action was due to requirements related to the accelerated approval status granted by the U.S. Food and Drug Administration (FDA) for MCL and MZL. Other approved indications for Imbruvica in the U.S. were not affected by this withdrawal and Imbruvica’s established clinical profile in other approved indications is unchanged. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

•AbbVie announced that the FDA approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval is based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.

•AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.

•AbbVie and Capsida Biotherapeutics Inc. (Capsida) announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. The collaboration builds on the partnership announced in 2021. Under the expanded collaboration, AbbVie’s extensive capabilities will be paired with Capsida’s novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs.

Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.62 – $11.02 to $10.72 – $11.12, which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2023. The company’s 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2023, as both cannot be reliably forecasted.

Chugai Announces 2023 1st Quarter Results

On April 27, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2023 (Press release, Chugai, APR 27, 2023, View Source;category= [SID1234630572]).

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"In the first quarter we saw an increase in both revenue and profits on a Core-basis due to steady growth of new and mainstay products. Sales increased both in Japan and overseas. Domestic sales were driven by new products Polivy and Vabysmo, mainstay products Hemlibra and Tecentriq, and the supply of Ronapreve to the government under the fiscal 2022 contract. Overseas sales increased from the growth of mainstay products. In R&D, Chugai’s crovalimab achieved the primary endpoint in its phase III clinical study and is scheduled to be filed for approval in Japan, the U.S., and Europe during the first half of this year. In addition, the foundation of future growth is steadily progressing, as evidenced by Chugai’s early-stage project SAIL66 entering the development pipeline, and the start of the full-scale operation of ‘Chugai Life Science Park Yokohama’ in April, which will serve as a center for innovation. Although contributions of COVID-19-related drugs will cease in the second quarter and beyond, sales of our global products and new/mainstay domestic products are strong, and projects that will contribute to mid-to long-term growth are progressing steadily. We will continue to strive to become a top innovator in the healthcare industry and deliver innovative new drugs to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

< First quarter results for 2023>

Chugai reported increased revenue and operating profit for the first quarter (Core-basis).

Revenue increased by 16.3% over the same period last year. Sales increased by approximately 20%, while other revenue decreased by approximately 20%. Domestic sales increased by approximately 20%. In the oncology field, the new product Polivy showed significant growth, and the mainstay product Tecentriq also contributed to the year-on-year increase despite the impact of biosimilars and NHI drug price revisions on mature products such as Avastin and Herceptin. In the specialty field, sales increased by approximately 30%, driven by the penetration of new products Vabysmo and Evrysdi, the supply of Ronapreve to the government, and the contribution of mainstay products Hemlibra and Enspryng. Overseas sales increased by approximately 20%. Sales of Alecensa increased significantly, more than tripling, and sales of Actemra remained strong. Other revenue decreased by approximately 20%, mainly due to the termination of royalty income from initial shipments of Hemlibra, despite the increase in royalties and profit-sharing income related to the intellectual property rights of Hemlibra. Revenue on IFRS basis, including Non-Core items, decreased due to the one-time impact of the lump-sum income from the settlement agreement with Alexion Pharmaceuticals, Inc in the previous year.

Cost to sales ratio rose by 4.8% points year-on-year to 51.8%, mainly due to a change in the product mix and the impact of foreign exchange. Research and development expenses increased mainly due to investments into drug discovery and early development, including the operation of Chugai Life Science Park Yokohama, and increases associated with the progress of development projects. Selling, general and administration expenses decreased mainly due to declines in various expenses. Other operating income (expense) was an income of ¥1.3 billion, mainly due to the recognition of gain on the sale of property, plant and equipment. As a result, Core operating profit totaled ¥105.4 billion (+6.6%).

The company also made good progress in research and development. Among our in-house projects that will contribute to mid to long-term profit growth, anti-C5 recycling anti-complement C5 recycling antibody crovalimab met the co-primary endpoints in the global Phase III clinical study in patients with paroxysmal nocturnal hemoglobinuria (PNH). Filing of applications for PNH is planned in Japan, the U.S., and Europe during the first half of this year. In addition, another phase I clinical study for crovalimab in lupus nephritis has newly started overseas. Furthermore, for GYM329, which is currently under development for several indications, a phase II study has started in facioscapulohumeral muscular dystrophy (FSHD), showing that simultaneous development of Chugai-originated projects is steadily progressing. Additionally, SAIL66, a novel antibody project which adopts Chugai’s proprietary antibody engineering technologies, entered the clinical development phase for solid tumors. For anti-IL-31 receptor A antibody nemolizumab, Galderma, the overseas licensee of the drug, announced that it achieved the primary endpoints in two phase III clinical studies for moderate to severe atopic dermatitis. Regarding projects in-licensed from Roche, late-stage clinical studies have started for the ophthalmic product Vabysmo and anti-CD20 antibody Gazyva for angioid streaks and pediatric nephrotic syndrome, respectively.

In April, Chugai Life Science Park Yokohama, a new research center combining the previous Fuji Gotemba Research Center and Kamakura Research Center, went into full operation, which will further advance drug discovery research to create innovation.

[2023 first quarter results]

Billion JPY 2023
Jan – Mar 2022
Jan – Mar % change
Core results
 Revenue 312.2 268.4 +16.3%
  Sales 291.5 242.7 +20.1%
  Other revenue* 20.7 25.7 -19.5%
 Operating profit 105.4 98.9 +6.6%
 Net income 78.4 70.6 +11.0%
IFRS results**
 Revenue 312.2 360.3 -13.3%
 Operating profit 98.3 187.0 -47.4%
 Net income 73.5 131.8 -44.2%
*Changed the title from "Royalties and other operating income" to "Other revenue".

**IFRS results in 2022 include non-Core items, such as the income and other related items, which totaled ¥90.7 billion associated with the settlement agreement between Chugai and Alexion Pharmaceuticals, Inc., which are excluded from the Core results Chugai adopts to manage recurring business activities.

[Sales breakdown]

Billion JPY 2023
Jan – Mar 2022
Jan – Mar % change
Sales 291.5 242.7 +20.1%
 Domestic sales 192.7 161.7 +19.2%
  Oncology 60.0 58.4 +2.7%
  Specialty 132.7 103.2 +28.6%
 Overseas sales 98.8 81.0 +22.0%

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.