On July 20, 2023 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2023 (Press release, Johnson & Johnson, JUL 20, 2023, View Source [SID1234633332]). "Our robust performance in the second quarter and first half of 2023 is a testament to the hard work and commitment of our colleagues around the world," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "We are entering the back half of the year from a position of strength with numerous catalysts, including becoming a two-sector company focused on Pharmaceutical and MedTech innovation."

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OVERALL FINANCIAL RESULTS:
overallresultsqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
Note: values may have been rounded

REGIONAL SALES RESULTS:
regionalsalesqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:
segmentsalesqtd.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: Values may have been rounded

SECOND QUARTER 2023 SEGMENT COMMENTARY:
Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 3.9%*. Excluding the COVID-19 Vaccine, adjusted operational sales grew 6.2%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), and CARVYKTI (ciltacabtagene autoleucel) in Oncology, STELARA (ustekinumab) and TREMFYA (guselkumab) in Immunology, UPTRAVI (selexipag) and OPSUMIT (macitentan) in Pulmonary Hypertension, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by ZYTIGA (abiraterone acetate) and IMBRUVICA (ibrutinib) in Oncology, COVID-19 Vaccine (Ad26.COV2.S) in Infectious Diseases, and REMICADE (infliximab) in Immunology.

MedTech
MedTech worldwide adjusted operational sales grew 9.9%*, driven primarily by electrophysiology products in Interventional Solutions, trauma in Orthopaedics, wound closure products in General Surgery, biosurgery in Advanced Surgery, and contact lenses in Vision. MedTech worldwide operational sales grew 14.7%*, with the acquisition of Abiomed contributing 4.8%.

Consumer Health
Consumer Health worldwide adjusted operational sales increased 7.7%* largely driven by over-the-counter (OTC) products. Major contributors to growth in OTC were TYLENOL and MOTRIN analgesics, upper respiratory products, international smoking cessation products, and IMODIUM in digestive health products. Additional contributors to growth were NEUTROGENA in Skin Health/Beauty products and Women’s Health products outside the United States.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory Janssen Marks First Approval Worldwide for AKEEGA (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations Press Release
Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation Press Release
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH) Press Release
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma Press Release
Data Release Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti-PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer Press Release
First Phase 3 TREMFYA (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis Press Release
New Data Published on Biosense Webster QDOT MICRO Catheter – the Latest Advancement in Focal RF Ablation for Treating AFib Press Release
Janssen to Highlight Scientific Advances and Commitment to Transform Cancer Care at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) with More than 90 Presentations Showcasing Robust, Differentiated Portfolio and Pipeline in Hematologic Malignancies and Solid Tumors Press Release
New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) Press Release
Janssen Announces Positive Topline Results for JNJ-2113—a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis1
Press Release
Treatment with RYBREVANT (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer1
Press Release

Other Johnson & Johnson Announces Launch of Kenvue Inc. IPO Roadshow Press Release
Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies Press Release

Subsequent to the quarter

FULL-YEAR 2023 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
July 2023
April 2023
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
6.0% – 7.0% / 6.5%
4.5% – 5.5% / 5.0%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$99.3B – $100.3B / $99.8B
7.0% – 8.0% / 7.5%
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$98.8B – $99.8B / $99.3B
6.5% – 7.5% / 7.0%
$97.9B – $98.9B / $98.4B
5.5% – 6.5% / 6.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.60 – $10.70 / $10.65
4.5% – 5.5% / 5.0%
$10.50 – $10.60 / $10.55
3.5% – 4.5% / 4.0%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.70 – $10.80 / $10.75
5.5% – 6.5% / 6.0%
$10.60 – $10.70 / $10.65
4.5% – 5.5% / 5.0%

On July 20, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it has executed financing to provide further working capital and support its ongoing business operations (Press release, ImmunityBio, JUL 20, 2023, View Source [SID1234633331]). The Company entered into a securities purchase agreement for a registered direct offering with multiple institutional investors, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $40 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gross proceeds of up to $48 million. In addition, in connection with the current financing, the Company agreed to amend the terms of the existing warrants issued in February 2023 so that the pricing and term of such warrants match the newly issued warrants.

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Jefferies LLC is acting as the exclusive placement agent for the registered direct offering.

The securities to be sold by the Company are offered under its shelf registration statement on Form S-3 (Registration No. 333-269608). A final prospectus supplement, which contains additional information relating to the offering, will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement may be obtained for free by contacting Jefferies, LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected].

Before investing in this offering, interested parties should read the prospectus supplement, the accompanying prospectus, and the other documents that are incorporated by reference in such prospectus supplement and the accompanying prospectus in their entirety.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 20, 2023 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 2,431 million in the second quarter of 2023 (Press release, Genmab, JUL 20, 2023, View Source [SID1234633330]). Net trade sales were USD 1,322 million in the U.S. and USD 1,110 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

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On July 20, 2023 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2023 (Press release, Abbott, JUL 20, 2023, View Source [SID1234633329]).

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Second-quarter GAAP diluted EPS of $0.78 and adjusted diluted EPS of $1.08, which excludes specified items.
Projected full-year 2023 diluted EPS on a GAAP basis of $3.02 to $3.22.
Projected full-year adjusted EPS of $4.30 to $4.50 remains unchanged but reflects an increased outlook for the underlying base business offset by a lower forecasted earnings contribution from COVID-19 testing-related sales.
Abbott now projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales1, to be in the low double-digits2 and COVID-19 testing-related sales of approximately $1.3 billion.
In May, Abbott received U.S. Food and Drug Administration (FDA) approval of its TactiFlex Ablation Catheter, Sensor Enabled, the world’s first ablation catheter with a unique flexible electrode tip and contact force sensing technology to treat patients with atrial fibrillation (AFib).
In June, Abbott announced its FreeStyle Libre 2 system is the first and only continuous glucose monitoring (CGM) system to receive expanded national reimbursement in France to now include all people with diabetes who use insulin.
In June, Abbott received U.S. FDA approval of its AVEIR dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacing system that treats people with abnormal heart rhythms.
"We’re achieving strong growth in our underlying base business," said Robert B. Ford, chairman and chief executive officer, Abbott. "We expect our highly productive pipeline to sustain the momentum we’re building this year and position us well for growth in the future."

SECOND-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI) is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second Quarter 2023 Results (2Q23)

Sales 2Q23 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

3,758

881

961

—

1,913

International

6,220

1,195

1,356

1,287

2,382

Total reported

9,978

2,076

2,317

1,287

4,295

% Change vs. 2Q22

U.S.

(23.2)

15.7

(60.7)

n/a

13.3

International

(2.3)

0.3

(26.8)

5.2

13.6

Total reported

(11.4)

6.3

(46.0)

5.2

13.5

Impact of foreign exchange

(2.5)

(3.0)

(1.3)

(7.4)

(1.9)

Impact of CSI acquisition

0.4

—

—

—

1.2

Impact of business exit

(0.1)

(0.6)

—

—

—

Organic

(9.2)

9.9

(44.7)

12.6

14.2

Impact of COVID-19 testing sales (3)

(20.7)

—

(51.8)

—

—

Organic (excluding COVID-19 tests)

11.5

9.9

7.1

12.6

14.2

U.S.

10.9

15.7

5.2

n/a

11.0

International

11.9

6.1

8.2

12.6

16.8

First Half 2023 Results (1H23)

Sales 1H23 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

7,686

1,693

2,296

—

3,691

International

12,039

2,350

2,709

2,476

4,504

Total reported

19,725

4,043

5,005

2,476

8,195

% Change vs. 1H22

U.S.

(21.8)

17.7

(55.4)

n/a

14.2

International

(9.6)

(2.4)

(38.4)

4.4

8.6

Total reported

(14.8)

5.1

(47.6)

4.4

11.0

Impact of foreign exchange

(2.9)

(3.4)

(1.6)

(7.5)

(2.9)

Impact of CSI acquisition

0.2

—

—

—

0.6

Impact of business exit

(0.2)

(1.6)

—

—

—

Organic

(11.9)

10.1

(46.0)

11.9

13.3

Impact of COVID-19 testing sales (3)

(22.6)

—

(51.7)

—

—

Organic (excluding COVID-19 tests)

10.7

10.1

5.7

11.9

13.3

U.S.

11.7

17.7

2.7

n/a

12.9

International

10.2

5.4

7.5

11.9

13.7

See table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

Nutrition

Second Quarter 2023 Results (2Q23)

Sales 2Q23 ($ in millions)

Total

Pediatric

Adult

U.S.

881

507

374

International

1,195

517

678

Total reported

2,076

1,024

1,052

% Change vs. 2Q22

U.S.

15.7

22.5

7.6

International

0.3

1.1

(0.2)

Total reported

6.3

10.6

2.5

Impact of foreign exchange

(3.0)

(2.3)

(3.5)

Impact of business exit

(0.6)

(1.6)

—

Organic

9.9

14.5

6.0

U.S.

15.7

22.5

7.6

International

6.1

7.5

5.2

Worldwide Nutrition sales increased 6.3 percent on a reported basis and 9.9 percent on an organic basis in the second quarter. Refer to table titled "Condensed Consolidated Statement of Earnings" for a reconciliation of adjusted historical revenue to reported revenue.

In Pediatric Nutrition, global sales increased 10.6 percent on a reported basis and 14.5 percent on an organic basis. In the U.S., sales growth of 22.5 percent was primarily driven by continued market share recovery in the infant formula business following a voluntary recall of certain products last year.

In Adult Nutrition, global sales increased 2.5 percent on a reported basis and 6.0 percent on an organic basis, which was led by strong global growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

View News Release Full Screen
First Half 2023 Results (1H23)

Sales 1H23 ($ in millions)

Total

Pediatric

Adult

U.S.

1,693

966

727

International

2,350

982

1,368

Total reported

4,043

1,948

2,095

% Change vs. 1H22

U.S.

17.7

28.6

5.8

International

(2.4)

(3.8)

(1.4)

Total reported

5.1

9.9

1.0

Impact of foreign exchange

(3.4)

(2.6)

(4.1)

Impact of business exit

(1.6)

(3.8)

—

Organic

10.1

16.3

5.1

U.S.

17.7

28.6

5.8

International

5.4

6.4

4.8

Diagnostics

Second Quarter 2023 Results (2Q23)

Sales 2Q23 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics *

U.S.

961

311

43

99

508

International

1,356

982

98

43

233

Total reported

2,317

1,293

141

142

741

% Change vs. 2Q22

U.S.

(60.7)

8.6

(40.1)

(2.3)

(74.4)

International

(26.8)

5.1

(29.9)

13.1

(68.5)

Total reported

(46.0)

5.9

(33.3)

1.9

(72.8)

Impact of foreign exchange

(1.3)

(3.6)

(1.2)

(0.5)

(0.5)

Organic

(44.7)

9.5

(32.1)

2.4

(72.3)

Impact of COVID-19 testing sales (3)

(51.8)

(0.6)

(30.8)

—

(75.6)

Organic (excluding COVID-19 tests)

7.1

10.1

(1.3)

2.4

3.3

U.S.

5.2

9.4

3.4

(2.3)

4.0

International

8.2

10.4

(3.1)

15.2

2.3

As expected, Diagnostics sales growth in the second quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $263 million in the second quarter of 2023 compared to $2.324 billion in the second quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 4.3 percent on a reported basis and 7.1 percent on an organic basis.

View News Release Full Screen
First Half 2023 Results (1H23)

Sales 1H23 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics *

U.S.

2,296

600

90

192

1,414

International

2,709

1,875

198

84

552

Total reported

5,005

2,475

288

276

1,966

% Change vs. 1H22

U.S.

(55.4)

8.2

(63.2)

0.1

(66.0)

International

(38.4)

1.3

(48.9)

11.2

(73.5)

Total reported

(47.6)

2.9

(54.4)

3.2

(68.5)

Impact of foreign exchange

(1.6)

(4.4)

(1.1)

(0.8)

(0.6)

Organic

(46.0)

7.3

(53.3)

4.0

(67.9)

Impact of COVID-19 testing sales (3)

(51.7)

(1.3)

(38.8)

—

(73.6)

Organic (excluding COVID-19 tests)

5.7

8.6

(14.5)

4.0

5.7

U.S.

2.7

9.2

(21.0)

0.1

1.5

International

7.5

8.5

(11.6)

14.0

12.3

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As
a result, $28 million of sales in the second quarter of 2022 and $57 million in the first half 2022 were moved from Rapid Diagnostics
to Heart Failure.

Established Pharmaceuticals

Second Quarter 2023 Results (2Q23)

Sales 2Q23 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,287

990

297

Total reported

1,287

990

297

% Change vs. 2Q22

U.S.

n/a

n/a

n/a

International

5.2

4.6

7.1

Total reported

5.2

4.6

7.1

Impact of foreign exchange

(7.4)

(8.4)

(4.4)

Organic

12.6

13.0

11.5

U.S.

n/a

n/a

n/a

International

12.6

13.0

11.5

Established Pharmaceuticals sales increased 5.2 percent on a reported basis and 12.6 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 4.6 percent on a reported basis and 13.0 percent on an organic basis, led by growth in several geographies and therapeutic areas, including gastroenterology, women’s health, and central nervous system/pain management.

First Half 2023 Results (1H23)

Sales 1H23 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

2,476

1,902

574

Total reported

2,476

1,902

574

% Change vs. 1H22

U.S.

n/a

n/a

n/a

International

4.4

2.7

10.8

Total reported

4.4

2.7

10.8

Impact of foreign exchange

(7.5)

(8.0)

(5.5)

Organic

11.9

10.7

16.3

U.S.

n/a

n/a

n/a

International

11.9

10.7

16.3

View News Release Full Screen
Medical Devices

Second Quarter 2023 Results (2Q23)

Sales 2Q23 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure *

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

1,913

269

245

226

264

219

185

505

International

2,382

314

308

69

451

279

42

919

Total reported

4,295

583

553

295

715

498

227

1,424

% Change vs. 2Q22

U.S.

13.3

2.0

8.8

8.9

15.4

5.9

17.6

26.6

International

13.6

10.3

18.7

11.9

6.1

19.8

5.1

15.8

Total reported

13.5

6.3

14.1

9.6

9.3

13.3

15.1

19.4

Impact of foreign exchange

(1.9)

(1.9)

(2.8)

(0.3)

(2.3)

(1.5)

(1.1)

(2.0)

Impact of CSI acquisition

1.2

—

—

—

6.6

—

—

—

Organic

14.2

8.2

16.9

9.9

5.0

14.8

16.2

21.4

U.S.

11.0

2.0

8.8

8.9

(1.9)

5.9

17.6

26.6

International

16.8

14.0

23.9

13.2

8.7

22.6

10.5

18.8

Worldwide Medical Devices sales increased 13.5 percent on a reported basis and 14.2 percent on an organic basis in the second quarter. Sales growth was led by double-digit organic growth in Diabetes Care, Electrophysiology, Structural Heart and Neuromodulation. Several recently launched products and new indications contributed to the strong performance, including Amplatzer Amulet, Navitor, TriClip, and Aveir.

In Electrophysiology, internationally, sales grew high-teens on a reported basis and more than 20 percent on an organic basis, which includes high-teens growth in Europe.

In Diabetes Care, FreeStyle Libre sales were $1.3 billion, which represents sales growth of 22.9 percent on a reported basis and 24.7 percent on an organic basis.

View News Release Full Screen
First Half 2023 Results (1H23)

Sales 1H23 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure *

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

3,691

529

483

444

482

429

340

984

International

4,504

581

575

132

850

530

83

1,753

Total reported

8,195

1,110

1,058

576

1,332

959

423

2,737

% Change vs. 1H22

U.S.

14.2

3.2

9.4

10.0

10.3

8.1

13.2

32.7

International

8.6

3.6

8.7

14.1

1.8

16.8

9.1

11.2

Total reported

11.0

3.4

9.0

10.9

4.7

12.8

12.4

18.1

Impact of foreign exchange

(2.9)

(2.8)

(3.8)

(0.8)

(3.1)

(2.7)

(1.4)

(3.1)

Impact of CSI acquisition

0.6

—

—

—

3.4

—

—

—

Organic

13.3

6.2

12.8

11.7

4.4

15.5

13.8

21.2

U.S.

12.9

3.2

9.4

10.0

1.3

8.1

13.2

32.7

International

13.7

8.9

15.7

17.4

6.1

22.0

16.1

15.8

On July 20, 2023 HUTCHMED (China) Limited reported that the Center for Drug Evaluation of China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer ("EMC") with pMMR1 tumors that have failed at least one line of platinum-based therapy (Filing, 6-K, Hutchison China MediTech, JUL 20, 2023, View Source [SID1234633327]). A study for potential registration of this combination in patients with previously treated advanced EMC in China has recently completed enrollment.

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It is a multi-center, open-label clinical study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab. Entry criteria include those EMC patients who experienced disease recurrence, disease progression or grade 3 or higher serious adverse events with treatment on platinum-based chemotherapy. The primary endpoint is independent review committee (IRC) assessed objective response rate ("ORR"), with secondary endpoints including disease control rate ("DCR"), progression free survival ("PFS"), overall survival ("OS"), as well as pharmacokinetic (PK) assessments. A total of 142 previously treated, advanced EMC patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT03903705.

Favorable results from this trial could lead to submission to the NMPA in the first half of 2024 for regulatory approval in this treatment setting.

About Breakthrough Therapy Designation in China

NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application ("NDA"). This indicates that the development and review of the therapy for this disease indication may be expedited, to address patients’ unmet needs more quickly.

About EMC

EMC is a type of cancer that begins in the uterus. Globally, an estimated 417,000 people were diagnosed with EMC and it caused approximately 97,000 deaths in 2020.2 Іn China, an estimated 82,000 people were diagnosed with EMC and it caused approximately 17,000 deaths in 2020.3 Although early-stage EMC can be surgically resected, recurrent and/or metastatic EMC remains an area of high unmet need with poor outcomes and limited treatment options.4,5,6

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date and is being investigated in combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing by the NMPA in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE for the treatment of patients with metastatic colorectal cancer ("CRC") who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). It has been included in the National Reimbursement Drug List ("NRDL") since January 2020.

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.

Filing of a rolling submission of NDA to the U.S. Food and Drug Administration ("FDA") was accepted and granted priority review in May 2023 with a Prescription Drug User Fee Act (PDUFA) date of November 30, 2023. Submission to the European Medicines Agency (EMA) was validated in June 2023, and submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is expected to be completed in 2023. The submissions to the FDA and the EMA include results from the Phase III FRESCO-2 trial along with data from the Phase III FRESCO trial conducted in China. FRESCO-2 is a global Phase III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care ("BSC") vs. placebo plus BSC in patients with previously treated metastatic CRC. The FRESCO-2 trial met its primary and key secondary endpoints, showing a significant and clinically meaningful improvement in OS and PFS, respectively. Fruquintinib has been generally well tolerated in patients to date (NCT04322539).7

An NDA to the NMPA was accepted in April 2023 for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma. The NDA includes results from the Phase III FRUTIGA trial, a study in China to evaluate fruquintinib combined with paclitaxel compared with paclitaxel monotherapy in this patient population. Its dual-primary endpoints were PFS and OS. The trial met the PFS endpoint at a statistically and clinically meaningful level, and while there was an improvement in median OS, the OS endpoint was not statistically significant. Statistically significant improvements were also shown in secondary endpoints including ORR, DCR and duration of response (DoR). The safety profile was consistent with previously reported studies (NCT03223376).

HUTCHMED is also developing fruquintinib in China for the treatment of multiple other solid tumor cancers in combination with anti-PD-1 monoclonal antibodies. Fruquintinib is licensed to Takeda Pharmaceutical Company Limited outside of China. HUTCHMED markets fruquintinib in China in partnership with Eli Lilly and Company.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent Biologics, Inc. and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.8 Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for seven indications and included in the NRDL for six indications.