Merck Announces Fourth-Quarter and Full-Year 2022 Financial Results

 
  • Fourth-Quarter and Full-Year 2022 Results Reflect Sustained Strong Revenue Growth
  •  
  • Fourth-Quarter 2022 Worldwide Sales Were $13.8 Billion, an Increase of 2% From Fourth Quarter 2021; Growth Excluding the Impact of Foreign Exchange Was 8%
  •  
  • Fourth-Quarter 2022 GAAP EPS From Continuing Operations Was $1.18; Fourth-Quarter 2022 Non-GAAP EPS Was $1.62
  •  
  • Full-Year 2022 Worldwide Sales Were $59.3 Billion, an Increase of 22% From Full Year 2021; Growth Excluding LAGEVRIO Was 12%; Growth Excluding LAGEVRIO and the Impact of Foreign Exchange Was 15%
    • KEYTRUDA Sales Grew 22% to $20.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27%
    •  
    • GARDASIL/GARDASIL 9 Sales Grew 22% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 27%
    •  
  •  
  • Full-Year 2022 GAAP EPS From Continuing Operations Was $5.71; Full-Year 2022 Non-GAAP EPS Was $7.48
  •  
  • In 2022, Augmented Pipeline Through Strategic Business Development, Including Acquisition of Imago and Key Agreements With Moderna, Orna, Orion and Kelun-Biotech
  •  
  • 2023 Financial Outlook
    • Anticipates Full-Year 2023 Worldwide Sales To Be Between $57.2 Billion and $58.7 Billion; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales
    •  
    • Expects Full-Year 2023 GAAP EPS To Be Between $5.86 and $6.01; Expects Non-GAAP EPS To Be Between $6.80 and $6.95
    •  
  •  

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2022.

 

"2022 was an exceptional year for Merck, which is a testament to the profound impact our medicines and vaccines are having on patients globally," said Robert M. Davis, chairman and chief executive officer. "I am extremely proud of what our talented and dedicated colleagues have accomplished scientifically, commercially and operationally. Our science-led strategy is working as we continue to build a sustainable engine that will drive innovation and generate long-term value for patients and shareholders well into the next decade."

 

   Financial Summary   

 

Financial information presented in this release reflects Merck's results on a continuing operations basis, which excludes Organon & Co. that was spun off in 2021.

 
                                                         
 

$ in millions, except EPS amounts

 
 

  Fourth Quarter  

 
 

  Year Ended  

 
 

  2022  

 
 

  2021  

 
 

  Change  

 
 

  Change  

 

  Ex-Exchange  

 
 

  Dec. 31,  

 

  2022  

 
 

  Dec. 31,  

 

  2021  

 
 

  Change  

 
 

  Change  

 

  Ex-Exchange  

 
 

Sales

 
 

$13,830

 
 

$13,521

 
 

2%

 
 

8%

 
 

$59,283

 
 

$48,704

 
 

22%

 
 

26%

 
 

GAAP net income 1

 
 

3,017

 
 

3,820

 
 

-21%

 
 

-17%

 
 

14,519

 
 

12,345

 
 

18%

 
 

21%

 
 

Non-GAAP net income that excludes certain items 1,2 *

 
 

4,129

 
 

4,592

 
 

-10%

 
 

-7%

 
 

19,005

 
 

13,623

 
 

40%

 
 

43%

 
 

GAAP EPS

 
 

1.18

 
 

1.51

 
 

-22%

 
 

-17%

 
 

5.71

 
 

4.86

 
 

17%

 
 

21%

 
 

Non-GAAP EPS that excludes certain items 2 *

 
 

1.62

 
 

1.81

 
 

-10%

 
 

-7%

 
 

7.48

 
 

5.37

 
 

39%

 
 

43%

 
 

*Refer to table on page 11.

 
 

Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.18 for the fourth quarter and $5.71 for the full year of 2022. Non-GAAP EPS was $1.62 for the fourth quarter and $7.48 for the full year of 2022. The declines in GAAP and non-GAAP EPS in the fourth quarter versus the prior year were primarily due to lower fourth quarter 2021 effective tax rates and the unfavorable impact of foreign exchange, partially offset by strong underlying business performance. The GAAP EPS decline in the fourth quarter also reflects the unfavorable impact of losses from investments in equity securities compared with gains in the prior year. Full-year 2022 and 2021 GAAP and non-GAAP EPS were negatively impacted by $0.22 and $0.65, respectively, related to an asset acquisition, and collaboration and licensing agreements.

 

Non-GAAP EPS excludes acquisition- and divestiture-related costs (including pretax intangible asset impairment research and development [R&D] charges of $780 million and $1.7 billion in the fourth quarter and full year of 2022, respectively, largely related to nemtabrutinib) and restructuring costs, as well as income and losses from investments in equity securities.

 

In 2022, the company changed the treatment of certain items for purposes of its non-GAAP reporting. Results for 2021 have been recast to conform to the new presentation. For more information, refer to the Form 8-K filed by the company on April 21, 2022.

 

   Oncology Program Highlights   

 
  • Merck announced the following regulatory and clinical milestones for KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy:
    • KEYTRUDA approved by the U.S. Food and Drug Administration (FDA) as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA non-small cell lung cancer (NSCLC), based on the pivotal Phase 3 KEYNOTE-091 trial.
    •  
    • In collaboration with Moderna, Inc. (Moderna), positive topline results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, which showed that KEYTRUDA in combination with mRNA-4157/V940, an investigational personalized mRNA therapeutic cancer vaccine, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival versus KEYTRUDA alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection.
    •  
    • In collaboration with Seagen Inc. and Astellas Pharma Inc., acceptance by the FDA for priority review of the supplemental Biologics License Application for KEYTRUDA in combination with Padcev® 3 (enfortumab vedotin-ejfv) for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
    •  
    • Positive topline results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
    •  
    • Positive topline results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the first-line treatment of patients with advanced or unresectable biliary tract cancer.
    •  
  •  
  • Merck announced that Lynparza (olaparib), an oral PARP inhibitor being co-developed and co-commercialized with AstraZeneca, was approved in the European Union (EU) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated, based on the Phase 3 PROpel trial.
  •  

   Vaccine Program Highlights   

 
  • Merck announced that an updated systematic literature review of 138 peer-reviewed studies observed that use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infection in women and men.
  •  

   Cardiovascular Program Highlights   

 
  • Merck will present results from the Phase 3 STELLAR study evaluating investigational sotatercept for the treatment of patients with pulmonary arterial hypertension, and from the Phase 2 study evaluating MK-0616, the company's investigational oral macrocyclic peptide PCSK9 inhibitor for the treatment of patients with hypercholesterolemia, at the American College of Cardiology's 72nd Annual Scientific Session together with the World Heart Federation's World Congress of Cardiology (ACC.23/WCC). Merck will host an investor event at ACC.23/WCC on March 6, 2023, to discuss these results. Further details will be announced at a later date.
  •  

   Business Development Highlights   

 
  • Merck announced and successfully completed the acquisition of Imago BioSciences, Inc. (Imago), for an approximate total equity value of $1.35 billion, expanding Merck's growing hematology portfolio.
  •  
  • Merck announced that it has expanded its relationship and entered into an exclusive license and collaboration agreement with Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd) to develop up to seven investigational preclinical antibody-drug conjugates (ADCs) for the treatment of cancer.
  •  

   Environmental, Social and Governance (ESG) Updates   

 
  • Merck was named one of America's most JUST companies by JUST Capital and CNBC, ranking No. 1 in the pharmaceuticals and biotech industry for the third straight year and No. 26 overall of all companies named.
  •  
  • Merck published its Sustainability Bond Allocation Report, which highlighted how the company's initial $1.0 billion sustainability bond is helping to drive progress across ESG focus areas.
  •  

   Fourth-Quarter and Full-Year Revenue Performance   

 

The following table reflects sales of the company's top pharmaceutical products, as well as sales of Animal Health products.

 
                                                                                                                                                                                                                                                                     
 

$ in millions

 
 

  Fourth Quarter  

 
 

  Year Ended  

 
 

 

 
 

  2022  

 
  

  2021  

 
  

  Change  

 
  

  Change  

 

  Ex-Exchange  

 
 

  Dec. 31,  

 

  2022  

 
  

  Dec. 31,  

 

  2021  

 
  

  Change  

 
  

  Change  

 

  Ex-Exchange  

 
 

Total Sales

 
 

$13,830

 
 

 

 
 

$13,521

 
 

 

 
 

2%

 
 

 

 
 

8%

 
 

$59,283

 
 

 

 
 

$48,704

 
 

 

 
 

22%

 
 

 

 
 

26%

 
 

Pharmaceutical

 
 

12,180

 
 

 

 
 

12,039

 
 

 

 
 

1%

 
 

 

 
 

9%

 
 

52,005

 
 

 

 
 

42,754

 
 

 

 
 

22%

 
 

 

 
 

28%

 
 

KEYTRUDA

 
 

5,450

 
 

 

 
 

4,577

 
 

 

 
 

19%

 
 

 

 
 

26%

 
 

20,937

 
 

 

 
 

17,186

 
 

 

 
 

22%

 
 

 

 
 

27%

 
 

GARDASIL / GARDASIL 9

 
 

1,470

 
 

 

 
 

1,528

 
 

 

 
 

-4%

 
 

 

 
 

6%

 
 

6,897

 
 

 

 
 

5,673

 
 

 

 
 

22%

 
 

 

 
 

27%

 
 

LAGEVRIO

 
 

825

 
 

 

 
 

952

 
 

 

 
 

-13%

 
 

 

 
 

2%

 
 

5,684

 
 

 

 
 

952

 
 

 

 
 

***

 
 

 

 
 

***

 
 

JANUVIA / JANUMET

 
 

913

 
 

 

 
 

1,393

 
 

 

 
 

-34%

 
 

 

 
 

-29%

 
 

4,513

 
 

 

 
 

5,288

 
 

 

 
 

-15%

 
 

 

 
 

-9%

 
 

PROQUAD, M-M-R II and VARIVAX

 
 

526

 
 

 

 
 

509

 
 

 

 
 

3%

 
 

 

 
 

6%

 
 

2,241

 
 

 

 
 

2,135

 
 

 

 
 

5%

 
 

 

 
 

7%

 
 

BRIDION

 
 

441

 
 

 

 
 

436

 
 

 

 
 

1%

 
 

 

 
 

7%

 
 

1,685

 
 

 

 
 

1,532

 
 

 

 
 

10%

 
 

 

 
 

16%

 
 

Lynparza*

 
 

292

 
 

 

 
 

268

 
 

 

 
 

9%

 
 

 

 
 

14%

 
 

1,116

 
 

 

 
 

989

 
 

 

 
 

13%

 
 

 

 
 

18%

 
 

Lenvima*

 
 

216

 
 

 

 
 

206

 
 

 

 
 

5%

 
 

 

 
 

9%

 
 

876

 
 

 

 
 

704

 
 

 

 
 

24%

 
 

 

 
 

28%

 
 

ROTATEQ

 
 

139

 
 

 

 
 

213

 
 

 

 
 

-35%

 
 

 

 
 

-31%

 
 

783

 
 

 

 
 

807

 
 

 

 
 

-3%

 
 

 

 
 

0%

 
 

SIMPONI

 
 

166

 
 

 

 
 

206

 
 

 

 
 

-19%

 
 

 

 
 

-8%

 
 

706

 
 

 

 
 

825

 
 

 

 
 

-14%

 
 

 

 
 

-4%

 
 

Animal Health

 
 

1,230

 
 

 

 
 

1,261

 
 

 

 
 

-2%

 
 

 

 
 

6%

 
 

5,550

 
 

 

 
 

5,568

 
 

 

 
 

0%

 
 

 

 
 

6%

 
 

Livestock

 
 

814

 
 

 

 
 

791

 
 

 

 
 

3%

 
 

 

 
 

12%

 
 

3,300

 
 

 

 
 

3,295

 
 

 

 
 

0%

 
 

 

 
 

7%

 
 

Companion Animals

 
 

416

 
 

 

 
 

470

 
 

 

 
 

-11%

 
 

 

 
 

-5%

 
 

2,250

 
 

 

 
 

2,273

 
 

 

 
 

-1%

 
 

 

 
 

4%

 
 

Other Revenues**

 
 

420

 
 

 

 
 

221

 
 

 

 
 

90%

 
 

 

 
 

-25%

 
 

1,728

 
 

 

 
 

382

 
 

 

 
 

***

 
 

 

 
 

87%

 
 

*Alliance revenue for this product represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.

 
 

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

 
 

***>100%

 
 

   Pharmaceutical Revenue   

 

Fourth-quarter pharmaceutical sales grew 1% to $12.2 billion. Excluding the unfavorable impact of foreign exchange, pharmaceutical sales grew 9%, primarily driven by oncology and hospital acute care, partially offset by diabetes.

 

Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 19% to $5.5 billion in the quarter. Global sales growth of KEYTRUDA reflects continued strong momentum from metastatic indications including certain types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer (TNBC) and microsatellite instability-high (MSI-H) cancers, and increased uptake across recent earlier-stage launches, including certain types of neoadjuvant/adjuvant TNBC in the U.S. Also contributing to growth in oncology was increased alliance revenue from Lynparza, which grew 9% to $292 million, driven primarily by higher demand in the U.S. In addition, sales of WELIREG (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor, increased to $40 million due to continued uptake in the U.S. following the product's launch in 2021.

 

Growth in hospital acute care reflects higher sales of ZERBAXA (ceftolozane and tazobactam), a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of patients with certain bacterial infections. ZERBAXA sales of $49 million in the fourth quarter of 2022 increased from $10 million in the fourth quarter of 2021, reflecting uptake from the completion of the phased resupply in 2022 that was initiated in the fourth quarter of 2021. Growth in hospital acute care also reflects higher sales of PREVYMIS (letermovir), a medicine for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogenic hematopoietic stem cell transplant, which increased 17% to $118 million, reflecting higher demand globally.

 

Vaccines sales performance reflects lower combined sales of GARDASIL and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, which declined 4% to $1.5 billion. Excluding the unfavorable impact of foreign exchange, GARDASIL/GARDASIL 9 sales grew 6%, reflecting higher demand outside of the U.S., particularly in China. Vaccines sales performance also reflects lower sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, which declined 50% to $145 million, primarily reflecting lower U.S. demand as the market continues to shift toward newer adult pneumococcal conjugate vaccines. In addition, sales of ROTATEQ (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children, declined 35% to $139 million, primarily due to lower sales in China, which benefited in the fourth quarter of 2021 from increased supply, and lower sales in the U.S. largely due to the timing of public-sector purchases. Vaccines sales performance benefited from the ongoing pediatric launch of VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to help prevent invasive pneumococcal disease, which had sales of $138 million, largely due to inventory stocking in the U.S.

 

Pharmaceutical sales growth was partially offset by lower combined sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), for the treatment of type 2 diabetes, which declined 34% to $913 million, primarily reflecting generic competition in certain international markets, particularly in Europe and the Asia Pacific region, and lower demand and net pricing in the U.S.

 

Sales of LAGEVRIO (molnupiravir), an investigational oral antiviral COVID-19 medicine, decreased 13% to $825 million. Excluding the unfavorable impact of foreign exchange, sales increased 2%, primarily driven by strong growth in Japan and the U.K. and the launch in Australia, offset by a decline in the U.S.

 

Full-year 2022 pharmaceutical sales grew 22% to $52.0 billion. Pharmaceutical sales growth was 16% excluding LAGEVRIO and the unfavorable impact of foreign exchange, primarily driven by higher sales in oncology, particularly KEYTRUDA, higher sales of vaccines, reflecting strong growth of GARDASIL/GARDASIL 9 and the ongoing pediatric launch of VAXNEUVANCE, as well as growth in hospital acute care products, including ZERBAXA and BRIDION (sugammadex) injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients ages 2 years and older undergoing surgery. Pharmaceutical sales growth in 2022 was partially offset by lower sales of JANUVIA and JANUMET, primarily reflecting lower demand in Europe as a result of generic competition, and a decline in PNEUMOVAX 23 sales as the U.S. market continues to shift toward newer adult pneumococcal conjugate vaccines. COVID-19-related disruptions negatively affected sales in 2022, but to a lesser extent than in 2021, which benefited year-over-year sales growth.

 

   Animal Health Revenue   

 

Animal Health sales totaled $1.2 billion for the fourth quarter of 2022, a 2% decline compared with the fourth quarter of 2021. Excluding the unfavorable effect of foreign exchange, Animal Health sales increased 6%. Sales growth of livestock products reflects higher demand, notably in the ruminant and poultry product portfolio, which includes technology solutions products, as well as higher pricing. Sales of companion animal products were negatively impacted by a reduction in veterinary visits in the broader companion animal market following the more favorable trend during the pandemic, as well as supply constraints for certain vaccines, partially offset by higher pricing.

 

Full-year 2022 Animal Health sales were $5.5 billion, in line with the prior year. Excluding the unfavorable effect of foreign exchange, Animal Health sales grew 6%, primarily due to higher pricing. Full-year sales growth was also driven by higher demand of livestock products, led by ruminant, poultry and swine products. Sales of companion animal products also reflect higher demand for the BRAVECTO (fluralaner) parasiticide line of products, which had sales of $1.0 billion, partially offset by supply constraints for certain vaccines.

 

   Fourth-Quarter and Full-Year Expense, EPS and Related Information   

 

The tables below present selected expense information.

 
                                                                                                                                                                         
 

$ in millions

 

 

 

  Fourth Quarter 2022  

 
  

  GAAP  

 
  

  Acquisition-  

 

  and  

 

  Divestiture-  

 

  Related Costs   4

 
  

  Restructuring  

 

  Costs  

 
  

  (Income) Loss  

 

  From  

 

  Investments in  

 

  Equity  

 

  Securities  

 
  

  Certain  

 

  Other  

 

  Items  

 
  

  Non-  

 

  GAAP   2

 
 

Cost of sales

 
  

$3,881

 
  

$482

 
  

$38

 
  

$-

 
  

$-

 
  

$3,361

 
 

Selling, general and administrative

 
  

2,687

 
  

39

 
  

20

 
  

-

 
  

-

 
  

2,628

 
 

Research and development

 
  

3,775

 
  

740

 
  

-

 
  

-

 
  

-

 
  

3,035

 
 

Restructuring costs

 
  

49

 
  

-

 
  

49

 
  

-

 
  

-

 
  

-

 
 

Other (income) expense, net

 
  

(75)

 
  

(69)

 
  

-

 
  

80

 
  

-

 
  

(86)

 
             
 

  Fourth Quarter 2021  

 
  

 

 
  

 

 
  

 

 
  

 

 
  

 

 
  

 

 
 

Cost of sales

 
  

$3,873

 
  

$419

 
  

$47

 
  

$-

 
  

$(4)

 
  

$3,411

 
 

Selling, general and administrative

 
  

2,830

 
  

226

 
  

10

 
  

-

 
  

-

 
  

2,594

 
 

Research and development

 
  

3,068

 
  

397

 
  

7

 
  

-

 
  

-

 
  

2,664

 
 

Restructuring costs

 
  

174

 
  

-

 
  

174

 
  

-

 
  

-

 
  

-

 
 

Other (income) expense, net

 
  

(333)

 
  

(3)

 
  

-

 
  

(381)

 
  

-

 
  

51

 
 
                                                                                                                                                                         
 

$ in millions

 

 

 

  Year Ended Dec. 31, 2022  

 
  

  GAAP  

 
  

  Acquisition-  

 

  and  

 

  Divestiture-  

 

  Related Costs   4

 
  

  Restructuring  

 

  Costs  

 
  

  (Income) Loss  

 

  From  

 

  Investments in  

 

  Equity  

 

  Securities  

 
  

  Certain  

 

  Other  

 

  Items  

 
  

  Non-  

 

  GAAP   2

 
 

Cost of sales

 
  

$17,411

 
  

$2,059

 
  

$205

 
  

$-

 
  

$-

 
  

$15,147

 
 

Selling, general and administrative

 
  

10,042

 
  

176

 
  

94

 
  

-

 
  

-

 
  

9,772

 
 

Research and development

 
  

13,548

 
  

1,676

 
  

30

 
  

-

 
  

-

 
  

11,842

 
 

Restructuring costs

 
  

337

 
  

-

 
  

337

 
  

-

 
  

-

 
  

-

 
 

Other (income) expense, net

 
  

1,501

 
  

(207)

 
  

-

 
  

1,348

 
  

-

 
  

360

 
             
 

  Year Ended Dec. 31, 2021  

 
  

 

 
  

 

 
  

 

 
  

 

 
  

 

 
  

 

 
 

Cost of sales

 
  

$13,626

 
  

$1,607

 
  

$160

 
  

$-

 
  

$221

 
  

$11,638

 
 

Selling, general and administrative

 
  

9,634

 
  

322

 
  

19

 
  

-

 
  

-

 
  

9,293

 
 

Research and development

 
  

12,245

 
  

479

 
  

28

 
  

-

 
  

-

 
  

11,738

 
 

Restructuring costs

 
  

661

 
  

-

 
  

661

 
  

-

 
  

-

 
  

-

 
 

Other (income) expense, net

 
  

(1,341)

 
  

76

 
  

-

 
  

(1,884)

 
  

-

 
  

467

 
 

   GAAP Expense, EPS and Related Information   

 

Gross margin was 71.9% for the fourth quarter of 2022 compared with 71.4% for the fourth quarter of 2021. The increase primarily reflects favorable product mix and foreign exchange. Gross margin was 70.6% for the full year of 2022 compared to 72.0% for the full year of 2021. The decline primarily reflects the unfavorable impacts of higher amortization of intangible assets, as well as higher revenue from third-party manufacturing arrangements and sales of LAGEVRIO, both of which have lower gross margins. The full-year gross margin decline was partially offset by the favorable effects of product mix, foreign exchange and charges in the prior year related to the discontinuation of COVID-19 development programs.

 

Selling, general and administrative (SG&A) expenses were $2.7 billion in the fourth quarter of 2022, a decrease of 5% compared to the fourth quarter of 2021. The decrease primarily reflects lower acquisition- and divestiture-related costs and the favorable effect of foreign exchange, partially offset by higher promotional spending, as well as higher administrative costs. Full-year SG&A expenses were $10.0 billion, an increase of 4% compared to the full year of 2021. The increase primarily reflects higher administrative costs, as well as higher promotional spending, partially offset by the favorable impact of foreign exchange and lower acquisition- and divestiture-related costs.

 

R&D expenses were $3.8 billion in the fourth quarter of 2022, an increase of 23% compared to the fourth quarter of 2021. The increase was primarily driven by higher intangible asset impairment charges related to nemtabrutinib, which were $780 million in the fourth quarter of 2022 compared with $275 million in the fourth quarter of 2021, lower reimbursement of LAGEVRIO R&D costs from Ridgeback Biotherapeutics (Ridgeback), higher compensation and benefit costs reflecting in part increased headcount to support expanded clinical development activity, and higher clinical development spending. R&D expenses were $13.5 billion for the full year of 2022, an increase of 11% compared with the full year of 2021. The increase was primarily driven by higher intangible asset impairment charges, which were $1.7 billion in 2022 compared with $275 million in 2021, largely related to nemtabrutinib, $690 million of charges in 2022 related to collaboration and licensing agreements with Moderna, Orna Therapeutics (Orna) and Orion Corporation (Orion), as well as higher compensation and benefit costs and clinical development spending. The increase was partially offset by a $1.7 billion charge in the prior year for the acquisition of Pandion Therapeutics, Inc. (Pandion).

 

Other (income) expense, net, was $75 million of income in the fourth quarter of 2022 compared to $333 million of income in the fourth quarter of 2021. Other (income) expense, net, was $1.5 billion of expense in the full year of 2022 compared to $1.3 billion of income in the full year of 2021. The change in both periods is primarily due to net losses from investments in equity securities in 2022 compared with net gains from investments in equity securities in 2021.

 

The effective tax rate for the fourth quarter of 2022 of 14.1% reflects the unfavorable impact of a higher than anticipated full-year rate of 11.7% due to a less favorable mix of income and expense than previously anticipated, while the effective tax rate for the fourth quarter of 2021 of 2.2% reflects the favorable impact of a lower than previously expected full-year 2021 rate of 11.0%.

 

GAAP EPS was $1.18 for the fourth quarter of 2022 compared to $1.51 for the fourth quarter of 2021. GAAP EPS was $5.71 for the full year of 2022 compared to $4.86 for the full year of 2021.

 

   Non-GAAP Expense, EPS and Related Information   

 

Non-GAAP gross margin was 75.7% for the fourth quarter of 2022 compared to 74.8% for the fourth quarter of 2021. The increase primarily reflects the favorable effects of product mix and foreign exchange. Non-GAAP gross margin was 74.4% for the full year of 2022 compared to 76.1% for the full year of 2021. The decrease primarily reflects the impact of higher revenue from third-party manufacturing arrangements and sales of LAGEVRIO, both of which have lower gross margins, partially offset by the favorable effects of product mix and foreign exchange.

 

Non-GAAP SG&A expenses were $2.6 billion in the fourth quarter of 2022, an increase of 1% compared to the fourth quarter of 2021. Non-GAAP SG&A expenses for the full year were $9.8 billion, an increase of 5% compared to the full year of 2021. The increase in both periods primarily reflects higher administrative costs, as well as higher promotional spending, partially offset by the favorable impact of foreign exchange.

 

Non-GAAP R&D expenses were $3.0 billion in the fourth quarter of 2022, an increase of 14% compared with the fourth quarter of 2021. The increase was primarily driven by lower reimbursement of LAGEVRIO R&D costs from Ridgeback, higher compensation and benefit costs reflecting in part increased headcount to support expanded clinical development activity, and higher clinical development spending. Non-GAAP R&D expenses were $11.8 billion for the full year of 2022, an increase of 1% compared with the full year of 2021. The increase was primarily driven by $690 million of charges in 2022 related to collaboration and licensing agreements with Moderna, Orna and Orion, as well as higher compensation and benefit costs and clinical development spending. The increase was partially offset by a $1.7 billion charge in the prior year for the acquisition of Pandion.

 

Non-GAAP other (income) expense, net, was $86 million of income in the fourth quarter of 2022 compared to $51 million of expense in the fourth quarter of 2021. Non-GAAP other (income) expense, net, was $360 million of expense in the full year of 2022 compared to $467 million of expense in the full year of 2021.

 

The non-GAAP effective tax rate for the fourth quarter of 2022 of 15.6% reflects the unfavorable impact of a higher than anticipated full-year rate of 14.2% due to a less favorable mix of income and expense than previously anticipated, while the non-GAAP effective tax rate for the fourth quarter of 2021 of 4.3% reflects the favorable impact of a lower than previously expected full-year 2021 rate of 12.4%.

 

Non-GAAP EPS was $1.62 for the fourth quarter of 2022 compared to $1.81 for the fourth quarter of 2021. Non-GAAP EPS was $7.48 for the full year of 2022 compared to $5.37 for the full year of 2021.

 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

 
                                                                                                                                                                                                  
 

$ in millions, except EPS amounts

 
  

  Fourth Quarter  

 
  

  Year Ended  

 
         
   

  2022  

 
  

  2021  

 
  

  Dec. 31, 2022  

 
  

  Dec. 31, 2021  

 
 

  EPS  

 
  

 

 
  

 

 
  

 

 
  

 

 
 

GAAP EPS

 
  

$1.18

 
  

$1.51

 
  

$5.71

 
  

$4.86

 
 

Difference

 
  

0.44

 
  

0.30

 
  

1.77

 
  

0.51

 
 

Non-GAAP EPS that excludes items listed below 2

 
  

$1.62

 
  

$1.81

 
  

$7.48

 
  

$5.37

 
 

 

 
  

 

 
  

 

 
  

 

 
  

 

 
 

  Net Income  

 
  

 

 
  

 

 
  

 

 
  

 

 
 

GAAP net income 1

 
  

$3,017

 
  

$3,820

 
  

$14,519

 
  

$12,345

 
 

Difference

 
  

1,112

 
  

772

 
  

4,486

 
  

1,278

 
 

Non-GAAP net income that excludes items listed below 1,2

 
  

$4,129

 
  

$4,592

 
  

$19,005

 
  

$13,623

 
 

 

 
  

 

 
  

 

 
  

 

 
  

 

 
 

  Decrease (Increase) in Net Income Due to Excluded Items:  

 
  

 

 
  

 

 
  

 

 
  

 

 
 

Acquisition- and divestiture-related costs 4

 
  

$1,192

 
  

$1,039

 
  

$3,704

 
  

$2,484

 
 

Restructuring costs

 
  

107

 
  

238

 
  

666

 
  

868

 
 

Loss (income) from investments in equity securities

 
  

80

 
  

(381)

 
  

1,348

 
  

(1,884)

 
 

Charges for the discontinuation of COVID-19 development programs

 
  

-

 
  

-

 
  

-

 
  

221

 
 

Other

 
  

-

 
  

(4)

 
  

-

 
  

-

 
 

Net decrease (increase) in income before taxes

 
  

1,379

 
  

892

 
  

5,718

 
  

1,689

 
 

Income tax (benefit) expense 5

 
  

(267)

 
  

(120)

 
  

(1,232)

 
  

(411)

 
 

Decrease (increase) in net income

 
  

$1,112

 
  

$772

 
  

$4,486

 
  

$1,278

 
 

   Financial Outlook   

 

The following table summarizes the company's full-year 2023 financial guidance.

 
                                 
   

  GAAP  

 
  

  Non-GAAP   2

 
 

Revenue*

 
  

$57.2 to $58.7 billion

 
  

$57.2 to $58.7 billion

 
 

Gross margin

 
  

Approximately 73%

 
  

Approximately 77%

 
 

Operating expenses**

 
  

$23.3 to $24.3 billion

 
  

$23.1 to $24.1 billion

 
 

Effective tax rate

 
  

17% to 18%

 
  

17% to 18%

 
 

EPS***

 
  

$5.86 to $6.01

 
  

$6.80 to $6.95

 
 

*Includes approximately $1.0 billion of LAGEVRIO sales. The company does not have any non-GAAP adjustments to revenue.

 
 

**Includes an aggregate $1.4 billion of R&D expenses related to the Imago acquisition and upfront payment for a license and collaboration agreement with Kelun-Biotech.

 
 

***Includes $0.53 of charges related to the Imago acquisition and upfront payment to Kelun-Biotech. EPS guidance for 2023 assumes a share count (assuming dilution) of approximately 2.55 billion shares.

 
 

Merck anticipates full-year 2023 revenue to be between $57.2 billion and $58.7 billion, including a negative impact of foreign exchange of approximately 2% at mid-January 2023 exchange rates. The company expects a significant decline in sales of LAGEVRIO, which are expected to be approximately $1.0 billion.

 

Merck expects full-year 2023 GAAP EPS to be between $5.86 and $6.01.

 

Merck expects full-year 2023 non-GAAP EPS to be between $6.80 and $6.95, including a negative impact of foreign exchange of approximately 4%. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs, as well as income and losses from investment in equity securities.

 

In the fourth quarter of 2022, Merck announced the acquisition of Imago for an approximate total value of $1.35 billion and a license and collaboration agreement with Kelun-Biotech, which includes an upfront payment of $175 million. The Imago acquisition closed in January 2023 and the collaboration with Kelun-Biotech is expected to close in the first quarter of 2023, resulting in the inclusion of an aggregate $1.4 billion of R&D expenses in Merck's GAAP and non-GAAP results for the first quarter and full year of 2023. The Imago acquisition is also anticipated to result in an approximate 1 percentage point unfavorable impact to Merck's expected full-year 2023 GAAP and non-GAAP tax rates. The impact of these two transactions on expected full-year 2023 GAAP and non-GAAP EPS is approximately $0.53. GAAP and non-GAAP EPS in 2022 were negatively impacted by $0.22 of charges related to the collaboration and licensing agreements with Moderna, Orna and Orion.

 

Operating expenses include incremental R&D spending to advance the development of the Imago and Kelun-Biotech programs, as well as other promising programs related to the collaboration and licensing agreements with Moderna, Orna and Orion.

 

The financial outlook does not assume additional significant potential business development transactions.

 

A reconciliation of anticipated 2023 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below.

 
                                 
 

$ in millions, except EPS amounts

 
  

  Full Year 2023  

 
 

 

 

GAAP EPS

 
  

$5.86 to $6.01

 
 

Difference

 
  

$0.94

 
 

Non-GAAP EPS that excludes items listed below 2

 
  

$6.80 to $6.95

 
 

 

 
  

 

 
 

Acquisition- and divestiture-related costs

 
  

$2,500

 
 

Restructuring costs

 
  

400

 
 

(Income) loss from investments in equity securities

 
  

(20)

 
 

Net decrease (increase) in income before taxes

 
  

$2,880

 
 

Estimated income tax (benefit) expense

 
  

(480)

 
 

Decrease (increase) in net income

 
  

$2,400

 
 

   Earnings Conference Call   

 

Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Thursday, Feb. 2, at 8:00 a.m. ET via this weblink . A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com .

 

All participants may join the call by dialing (888) 769-8514 (U.S. Toll-Free) or (517) 308-9208 (International) and using the access code 8206435.

 

  About Merck  

 

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

 

  Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA  

 

This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021, and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

 
     
 

  1 Net income from continuing operations attributable to Merck & Co., Inc.

 
 

  2 Merck is providing certain 2022 and 2021 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the company's results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using a non-GAAP pre-tax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. Non-GAAP results for 2021 have been recast to conform to presentation changes implemented in 2022.

 
 

  3 Registered trademark of Seagen and Agensys.

 
 

  4 Includes expenses for the amortization of intangible assets and purchase accounting adjustments to inventories recognized as a result of acquisitions, intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. R&D expenses include intangible asset impairment charges of $780 million and $1.7 billion in fourth quarter and full year 2022, respectively, and $275 million in both fourth quarter and full year 2021, largely related to nemtabrutinib, which was obtained as part of the 2020 acquisition of ArQule, Inc. Also includes integration, transaction and certain other costs related to acquisitions and divestitures.

 
 

  5 Includes the estimated tax impact on the reconciling items. In addition, the amount for full-year 2021 includes a $207 million net tax benefit related to the settlement of certain federal income tax matters.

 
 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
 

  MERCK & CO., INC.  

 
 

  CONSOLIDATED STATEMENT OF INCOME - GAAP  

 
 

  (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)  

 
 

  (UNAUDITED)  

 
 

  Table 1  

 
           
 

On June 2, 2021, Merck completed the spinoff of products from its women's health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon). The historical results of the businesses that were contributed to Organon in the spin-off are excluded from sales and expenses below and reflected as discontinued operations in the company's Consolidated Statements of Income provided below.

 
           
   

  GAAP  

 
  

  % Change  

 
  

  GAAP  

 
  

  % Change  

 
     
   

  4Q22  

 
 

  4Q21  

 
   

  Full Year  

 

  2022  

 
 

  Full Year  

 

  2021  

 
 
     
           
Sales   

$

 
 

13,830

 
 

 

 
 

$

 
 

13,521

 
 

 

 
  

2

 
 

%

 
  

$

 
 

59,283

 
 

 

 
 

$

 
 

48,704

 
 

 

 
  

22

 
 

%

 
           
Costs, Expenses and Other           
Cost of sales   

 

 
 

3,881

 
 

 

 
 

 

 
 

3,873

 
 

 

 
  

0

 
 

%

 
  

 

 
 

17,411

 
 

 

 
 

 

 
 

13,626

 
 

 

 
  

28

 
 

%

 
Selling, general and administrative   

 

 
 

2,687

 
 

 

 
 

 

 
 

2,830

 
 

 

 
  

-5

 
 

%

 
  

 

 
 

10,042

 
 

 

 
 

 

 
 

9,634

 
 

 

 
  

4

 
 

%

 
Research and development   

 

 
 

3,775

 
 

 

 
 

 

 
 

3,068

 
 

 

 
  

23

 
 

%

 
  

 

 
 

13,548

 
 

 

 
 

 

 
 

12,245

 
 

 

 
  

11

 
 

%

 
Restructuring costs   

 

 
 

49

 
 

 

 
 

 

 
 

174

 
 

 

 
  

-72

 
 

%

 
  

 

 
 

337

 
 

 

 
 

 

 
 

661

 
 

 

 
  

-49

 
 

%

 
Other (income) expense, net   

 

 
 

(75

 
 

)

 
 

 

 
 

(333

 
 

)

 
  

-77

 
 

%

 
  

 

 
 

1,501

 
 

 

 
 

 

 
 

(1,341

 
 

)

 
  *
Income from Continuing Operations Before Taxes   

 

 
 

3,513

 
 

 

 
 

 

 
 

3,909

 
 

 

 
  

-10

 
 

%

 
  

 

 
 

16,444

 
 

 

 
 

 

 
 

13,879

 
 

 

 
  

18

 
 

%

 
Income Tax Provision   

 

 
 

495

 
 

 

 
 

 

 
 

85

 
 

 

 
    

 

 
 

1,918

 
 

 

 
 

 

 
 

1,521

 
 

 

 
  
Net Income from Continuing Operations   

 

 
 

3,018

 
 

 

 
 

 

 
 

3,824

 
 

 

 
  

-21

 
 

%

 
  

 

 
 

14,526

 
 

 

 
 

 

 
 

12,358

 
 

 

 
  

18

 
 

%

 
Less: Net Income Attributable to Noncontrolling Interests   

 

 
 

1

 
 

 

 
 

 

 
 

4

 
 

 

 
    

 

 
 

7

 
 

 

 
 

 

 
 

13

 
 

 

 
  
Net Income from Continuing Operations Attributable to Merck & Co., Inc.   

 

 
 

3,017

 
 

 

 
 

 

 
 

3,820

 
 

 

 
  

-21

 
 

%

 
  

 

 
 

14,519

 
 

 

 
 

 

 
 

12,345

 
 

 

 
  

18

 
 

%

 
(Loss) Income from Discontinued Operations, Net of Taxes and Amounts Attributable to Noncontrolling Interests   

 

 
 

-

 
 

 

 
 

 

 
 

(62

 
 

)

 
  *   

 

 
 

-

 
 

 

 
 

 

 
 

704

 
 

 

 
  *
Net Income Attributable to Merck & Co., Inc.   

$

 
 

3,017

 
 

 

 
 

$

 
 

3,758

 
 

 

 
  

-20

 
 

%

 
  

$

 
 

14,519

 
 

 

 
 

$

 
 

13,049

 
 

 

 
  

11

 
 

%

 
           
Basic Earnings (Loss) per Common Share Attributable to Merck & Co., Inc. Common Shareholders:           
Income from Continuing Operations   

$

 
 

1.19

 
 

 

 
 

$

 
 

1.51

 
 

 

 
  

-21

 
 

%

 
  

$

 
 

5.73

 
 

 

 
 

$

 
 

4.88

 
 

 

 
  

17

 
 

%

 
(Loss) Income from Discontinued Operations   

 

 
 

-

 
 

 

 
 

 

 
 

(0.02

 
 

)

 
  *   

 

 
 

-

 
 

 

 
 

 

 
 

0.28

 
 

 

 
  *
Net Income   

$

 
 

1.19

 
 

 

 
 

$

 
 

1.49

 
 

 

 
  

-20

 
 

%

 
  

$

 
 

5.73

 
 

 

 
 

$

 
 

5.16

 
 

 

 
  

11

 
 

%

 
           
Earnings (Loss) per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders:           
Income from Continuing Operations   

$

 
 

1.18

 
 

 

 
 

$

 
 

1.51

 
 

 

 
  

-22

 
 

%

 
  

$

 
 

5.71

 
 

 

 
 

$

 
 

4.86

 
 

 

 
  

17

 
 

%

 
(Loss) Income from Discontinued Operations   

 

 
 

-

 
 

 

 
 

 

 
 

(0.02

 
 

)

 
  *   

 

 
 

-

 
 

 

 
 

 

 
 

0.28

 
 

 

 
  *
Net Income   

$

 
 

1.18

 
 

 

 
 

$

 
 

1.48

 
 

 

 
  

-20

 
 

%

 
  

$

 
 

5.71

 
 

 

 
 

$

 
 

5.14

 
 

 

 
  

11

 
 

%

 
           
Average Shares Outstanding   

 

 
 

2,536

 
 

 

 
 

 

 
 

2,527

 
 

 

 
    

 

 
 

2,532

 
 

 

 
 

 

 
 

2,530

 
 

 

 
  
Average Shares Outstanding Assuming Dilution   

 

 
 

2,548

 
 

 

 
 

 

 
 

2,535

 
 

 

 
    

 

 
 

2,542

 
 

 

 
 

 

 
 

2,538

 
 

 

 
  
Tax Rate from Continuing Operations   

 

 
 

14.1

 
 

%

 
 

 

 
 

2.2

 
 

%

 
    

 

 
 

11.7

 
 

%

 
 

 

 
 

11.0

 
 

%

 
  
           
           
 

* 100% or greater

 
          
 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
  MERCK & CO., INC.  
  FOURTH QUARTER AND FULL YEAR 2022 GAAP TO NON-GAAP RECONCILIATION - CONTINUING OPERATIONS  
  (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES)  
  (UNAUDITED)  
  Table 2a  
             
   

  GAAP  

 
  

  Acquisition and Divestiture-  

 

  Related Costs (1)  

 
  

  Restructuring Costs (2)  

 
  

  (Income) Loss from  

 

  Investments in Equity  

 

  Securities  

 
  

  Adjustment Subtotal  

 
  

  Non-GAAP  

 
       
  Fourth Quarter              
Cost of sales   

  $  

 
 

  3,881  

 
 

 

 
  

482

 
 

 

 
  

38

 
 

 

 
    

520

 
 

 

 
  

$

 
 

3,361

 
 

 

 
Selling, general and administrative   

 

 
 

  2,687  

 
 

 

 
  

39

 
 

 

 
  

20

 
 

 

 
    

59

 
 

 

 
  

 

 
 

2,628

 
 

 

 
Research and development   

 

 
 

  3,775  

 
 

 

 
  

740

 
 

 

 
      

740

 
 

 

 
  

 

 
 

3,035

 
 

 

 
Restructuring costs   

 

 
 

  49  

 
 

 

 
    

49

 
 

 

 
    

49

 
 

 

 
  

 

 
 

-

 
 

 

 
Other (income) expense, net   

 

 
 

  (75  

 
 

  )  

 
  

(69

 
 

)

 
    

80

 
 

 

 
  

11

 
 

 

 
  

 

 
 

(86

 
 

)

 
Income from Continuing Operations Before Taxes   

 

 
 

  3,513  

 
 

 

 
  

(1,192

 
 

)

 
  

(107

 
 

)

 
  

(80

 
 

)

 
  

(1,379

 
 

)

 
  

 

 
 

4,892

 
 

 

 
Income Tax Provision (Benefit)   

 

 
 

  495  

 
 

 

 
  

(222

 
 

)

 
 

  (3)

 
 

(32

 
 

)

 
 

  (3)

 
 

(13

 
 

)

 
 

  (3)

 
 

(267

 
 

)

 
  

 

 
 

762

 
 

 

 
Net Income from Continuing Operations   

 

 
 

  3,018  

 
 

 

 
  

(970

 
 

)

 
  

(75

 
 

)

 
  

(67

 
 

)

 
  

(1,112

 
 

)

 
  

 

 
 

4,130

 
 

 

 
Net Income from Continuing Operations Attributable to Merck & Co., Inc.   

 

 
 

  3,017  

 
 

 

 
  

(970

 
 

)

 
  

(75

 
 

)

 
  

(67

 
 

)

 
  

(1,112

 
 

)

 
  

 

 
 

4,129

 
 

 

 
Earnings per Common Share Assuming Dilution from Continuing Operations   

  $  

 
 

  1.18  

 
 

 

 
  

(0.38

 
 

)

 
  

(0.03

 
 

)

 
  

(0.03

 
 

)

 
  

(0.44

 
 

)

 
  

$

 
 

1.62

 
 

 

 
             
Tax Rate   

 

 
 

  14.1  

 
 

  %  

 
          

 

 
 

15.6

 
 

%

 
             
             
  Full Year              
Cost of sales   

  $  

 
 

  17,411  

 
 

 

 
  

2,059

 
 

 

 
  

205

 
 

 

 
    

2,264

 
 

 

 
  

$

 
 

15,147

 
 

 

 
Selling, general and administrative   

 

 
 

  10,042  

 
 

 

 
  

176

 
 

 

 
  

94

 
 

 

 
    

270

 
 

 

 
  

 

 
 

9,772

 
 

 

 
Research and development   

 

 
 

  13,548  

 
 

 

 
  

1,676

 
 

 

 
  

30

 
 

 

 
    

1,706

 
 

 

 
  

 

 
 

11,842

 
 

 

 
Restructuring costs   

 

 
 

  337  

 
 

 

 
    

337

 
 

 

 
    

337

 
 

 

 
  

 

 
 

-

 
 

 

 
Other (income) expense, net   

 

 
 

  1,501  

 
 

 

 
  

(207

 
 

)

 
    

1,348

 
 

 

 
  

1,141

 
 

 

 
  

 

 
 

360

 
 

 

 
Income from Continuing Operations Before Taxes   

 

 
 

  16,444  

 
 

 

 
  

(3,704

 
 

)

 
  

(666

 
 

)

 
  

(1,348

 
 

)

 
  

(5,718

 
 

)

 
  

 

 
 

22,162

 
 

 

 
Income Tax Provision (Benefit)   

 

 
 

  1,918  

 
 

 

 
  

(809

 
 

)

 
 

  (3)

 
 

(129

 
 

)

 
 

  (3)

 
 

(294

 
 

)

 
 

  (3)

 
 

(1,232

 
 

)

 
  

 

 
 

3,150

 
 

 

 
Net Income from Continuing Operations   

 

 
 

  14,526  

 
 

 

 
  

(2,895

 
 

)

 
  

(537

 
 

)

 
  

(1,054

 
 

)

 
  

(4,486

 
 

)

 
  

 

 
 

19,012

 
 

 

 
Net Income from Continuing Operations Attributable to Merck & Co., Inc.   

 

 
 

  14,519  

 
 

 

 
  

(2,895

 
 

)

 
  

(537

 
 

)

 
  

(1,054

 
 

)

 
  

(4,486

 
 

)

 
  

 

 
 

19,005

 
 

 

 
Earnings per Common Share Assuming Dilution from Continuing Operations   

  $  

 
 

  5.71  

 
 

 

 
  

(1.14

 
 

)

 
  

(0.21

 
 

)

 
  

(0.42

 
 

)

 
  

(1.77

 
 

)

 
  

$

 
 

7.48

 
 

 

 
             
Tax Rate   

 

 
 

  11.7  

 
 

  %  

 
          

 

 
 

14.2

 
 

%

 
 
     
 

Only the line items that are affected by non-GAAP adjustments are shown.

 
 

Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors' understanding of the company's results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, senior management's annual compensation is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP.

 
 

  (1) Amounts included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses for the fourth quarter and full year primarily reflect $780 million and $1.7 billion, respectively, of intangible asset impairment charges largely related to nemtabrutinib, which was obtained as part of the 2020 ArQule, Inc. acquisition, and expenses for the amortization of intangible assets, partially offset by a reduction in expenses related to changes in the estimated fair value of liabilities for contingent consideration. Amounts included in other (income) expense, net, for the fourth quarter and full year reflect royalty income and decreases in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture.

 
 

  (2) Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the company's formal restructuring programs.

 
 

  (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments.

 
 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
  MERCK & CO., INC.  
  FRANCHISE / KEY PRODUCT SALES - CONTINUING OPERATIONS  
  (AMOUNTS IN MILLIONS)  
  (UNAUDITED)  
  Table 3  
                  
  

  2022  

 
  

  2021  

 
  

  4Q  

 
  

  Full Year  

 
  

  1Q  

 
 

  2Q  

 
 

  3Q  

 
 

  4Q  

 
 

  Full Year  

 
  

  1Q  

 
 

  2Q  

 
 

  3Q  

 
 

  4Q  

 
 

  Full Year  

 
  

  Nom %  

 
 

  Ex-Exch %  

 
  

  Nom %  

 
 

  Ex-Exch %  

 
                  
  TOTAL SALES (1)   

  $15,901  

 
 

  $14,593  

 
 

  $14,959  

 
 

  $13,830  

 
 

  $59,283  

 
  

  $10,627  

 
 

  $11,402  

 
 

  $13,154  

 
 

  $13,521  

 
 

  $48,704  

 
  

  2  

 
 

  8  

 
 

 

 
 

  22  

 
 

  26  

 
  PHARMACEUTICAL   

  14,107  

 
 

  12,756  

 
 

  12,963  

 
 

  12,180  

 
 

  52,005  

 
  

  9,238  

 
 

  9,980  

 
 

  11,496  

 
 

  12,039  

 
 

  42,754  

 
  

  1  

 
 

  9  

 
 

 

 
 

  22  

 
 

  28  

 
  Oncology   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Keytruda  

4,809

 
 

5,252

 
 

5,426

 
 

5,450

 
 

20,937

 
  

3,899

 
 

4,176

 
 

4,534

 
 

4,577

 
 

17,186

 
  

19

 
 

26

 
 

 

 
 

22

 
 

27

 
Alliance Revenue – Lynparza (2)  

266

 
 

275

 
 

284

 
 

292

 
 

1,116

 
  

228

 
 

248

 
 

246

 
 

268

 
 

989

 
  

9

 
 

14

 
 

 

 
 

13

 
 

18

 
Alliance Revenue – Lenvima (2)  

227

 
 

231

 
 

202

 
 

216

 
 

876

 
  

130

 
 

181

 
 

188

 
 

206

 
 

704

 
  

5

 
 

9

 
 

 

 
 

24

 
 

28

 
Alliance Revenue – Reblozyl (3)  

52

 
 

33

 
 

39

 
 

41

 
 

166

 
  

 

 
 

 

 
 

 

 
 

17

 
 

17

 
  

145

 
 

145

 
 

 

 
 

*

 
 

*

 
  Vaccines (4)   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Gardasil / Gardasil 9  

1,460

 
 

1,674

 
 

2,294

 
 

1,470

 
 

6,897

 
  

917

 
 

1,234

 
 

1,993

 
 

1,528

 
 

5,673

 
  

-4

 
 

6

 
 

 

 
 

22

 
 

27

 
ProQuad / M-M-R II / Varivax  

470

 
 

578

 
 

668

 
 

526

 
 

2,241

 
  

449

 
 

516

 
 

661

 
 

509

 
 

2,135

 
  

3

 
 

6

 
 

 

 
 

5

 
 

7

 
RotaTeq  

216

 
 

173

 
 

256

 
 

139

 
 

783

 
  

158

 
 

208

 
 

227

 
 

213

 
 

807

 
  

-35

 
 

-31

 
 

 

 
 

-3

 
 

0

 
Pneumovax 23  

173

 
 

153

 
 

131

 
 

145

 
 

602

 
  

171

 
 

152

 
 

277

 
 

292

 
 

893

 
  

-50

 
 

-47

 
 

 

 
 

-33

 
 

-30

 
Vaqta  

36

 
 

35

 
 

64

 
 

39

 
 

173

 
  

34

 
 

56

 
 

48

 
 

41

 
 

179

 
  

-5

 
 

-2

 
 

 

 
 

-3

 
 

-2

 
  Hospital Acute Care   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Bridion  

395

 
 

426

 
 

423

 
 

441

 
 

1,685

 
  

340

 
 

387

 
 

369

 
 

436

 
 

1,532

 
  

1

 
 

7

 
 

 

 
 

10

 
 

16

 
Prevymis  

94

 
 

103

 
 

114

 
 

118

 
 

428

 
  

82

 
 

93

 
 

96

 
 

100

 
 

370

 
  

17

 
 

28

 
 

 

 
 

16

 
 

24

 
Dificid  

52

 
 

66

 
 

77

 
 

67

 
 

263

 
  

27

 
 

34

 
 

54

 
 

60

 
 

175

 
  

12

 
 

12

 
 

 

 
 

50

 
 

50

 
Primaxin  

58

 
 

64

 
 

63

 
 

54

 
 

239

 
  

65

 
 

60

 
 

70

 
 

65

 
 

259

 
  

-17

 
 

-7

 
 

 

 
 

-8

 
 

-4

 
Noxafil  

57

 
 

60

 
 

62

 
 

58

 
 

238

 
  

67

 
 

66

 
 

64

 
 

62

 
 

259

 
  

-5

 
 

7

 
 

 

 
 

-8

 
 

-1

 
Invanz  

52

 
 

46

 
 

50

 
 

40

 
 

189

 
  

57

 
 

48

 
 

53

 
 

45

 
 

202

 
  

-10

 
 

-2

 
 

 

 
 

-7

 
 

-1

 
Cancidas  

53

 
 

42

 
 

43

 
 

36

 
 

174

 
  

57

 
 

54

 
 

56

 
 

45

 
 

212

 
  

-19

 
 

-10

 
 

 

 
 

-18

 
 

-14

 
Zerbaxa  

30

 
 

46

 
 

43

 
 

49

 
 

169

 
  

(8)

 
 

(1)

 
 

(2)

 
 

10

 
 

(1)

 
  

*

 
 

*

 
 

 

 
 

*

 
 

*

 
  Cardiovascular   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Alliance Revenue - Adempas/Verquvo (5)  

72

 
 

98

 
 

88

 
 

82

 
 

341

 
  

74

 
 

74

 
 

100

 
 

94

 
 

342

 
  

-12

 
 

-12

 
 

 

 
 

-

 
 

-

 
Adempas (6)  

61

 
 

63

 
 

57

 
 

57

 
 

238

 
  

55

 
 

74

 
 

59

 
 

63

 
 

252

 
  

-10

 
 

6

 
 

 

 
 

-6

 
 

7

 
  Virology   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Lagevrio  

3,247

 
 

1,177

 
 

436

 
 

825

 
 

5,684

 
  

 

 
 

 

 
 

 

 
 

952

 
 

952

 
  

-13

 
 

2

 
 

 

 
 

*

 
 

*

 
Isentress / Isentress HD  

158

 
 

147

 
 

161

 
 

167

 
 

633

 
  

209

 
 

192

 
 

189

 
 

178

 
 

769

 
  

-7

 
 

-1

 
 

 

 
 

-18

 
 

-13

 
  Neuroscience   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Belsomra  

69

 
 

69

 
 

62

 
 

59

 
 

258

 
  

79

 
 

78

 
 

81

 
 

80

 
 

318

 
  

-27

 
 

-14

 
 

 

 
 

-19

 
 

-9

 
  Immunology   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Simponi  

186

 
 

181

 
 

173

 
 

166

 
 

706

 
  

214

 
 

202

 
 

203

 
 

206

 
 

825

 
  

-19

 
 

-8

 
 

 

 
 

-14

 
 

-4

 
Remicade  

61

 
 

53

 
 

49

 
 

44

 
 

207

 
  

85

 
 

75

 
 

73

 
 

67

 
 

299

 
  

-34

 
 

-22

 
 

 

 
 

-31

 
 

-21

 
  Diabetes (7)   

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
Januvia  

779

 
 

756

 
 

717

 
 

561

 
 

2,813

 
  

809

 
 

784

 
 

852

 
 

878

 
 

3,324

 
  

-36

 
 

-31

 
 

 

 
 

-15

 
 

-11

 
Janumet  

454

 
 

476

 
 

417

 
 

353

 
 

1,700

 
  

486

 
 

477

 
 

487

 
 

514

 
 

1,964

 
  

-31

 
 

-25

 
 

 

 
 

-13

 
 

-7

 
  Other Pharmaceutical (8)   

520

 
 

479

 
 

564

 
 

685

 
 

2,249

 
  

554

 
 

512

 
 

518

 
 

533

 
 

2,118

 
  

29

 
 

37

 
 

 

 
 

6

 
 

12

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  ANIMAL HEALTH   

  1,482  

 
 

  1,467  

 
 

  1,371  

 
 

  1,230  

 
 

  5,550  

 
  

  1,418  

 
 

  1,472  

 
 

  1,417  

 
 

  1,261  

 
 

  5,568  

 
  

  -2  

 
 

  6  

 
 

 

 
 

  -  

 
 

  6  

 
Livestock  

832

 
 

826

 
 

829

 
 

814

 
 

3,300

 
  

819

 
 

821

 
 

864

 
 

791

 
 

3,295

 
  

3

 
 

12

 
 

 

 
 

-

 
 

7

 
Companion Animals  

650

 
 

641

 
 

542

 
 

416

 
 

2,250

 
  

599

 
 

651

 
 

553

 
 

470

 
 

2,273

 
  

-11

 
 

-5

 
 

 

 
 

-1

 
 

4

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  

 

 
 

 

 
 

 

 
 

 

 
 

 

 
  Other Revenues (9)   

  312  

 
 

  370  

 
 

  625  

 
 

  420  

 
 

  1,728  

 
  

  (29)  

 
 

  (50)  

 
 

  241  

 
 

  221  

 
 

  382  

 
  

  90  

 
 

  -25  

 
 

 

 
 

  *  

 
 

  87  

 
                  
                  
 

* 200% or greater

 
                 
 
                      
 

Sum of quarterly amounts may not equal year-to-date amounts due to rounding.

 
            
 

  (1) Only select products are shown.

 
 

  (2) Alliance Revenue represents Merck's share of profits, which are product sales net of cost of sales and commercialization costs.

 
 

  (3) Alliance Revenue represents royalties and a milestone payment.

 
 

  (4) Total Vaccines sales were $2,481 million, $2,709 million, $3,552 million and $2,554 million in the first, second, third and fourth quarter of 2022, respectively, and $1,809 million, $2,293 million, $3,315 million and $2,715 million in the first, second, third and fourth quarter of 2021, respectively.

 
 

  (5) Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs.

 
 

  (6) Net product sales in Merck's marketing territories.

 
 

  (7) Total Diabetes sales were $1,305 million, $1,300 million, $1,231 million and $1,012 million in the first, second, third quarter and fourth quarter of 2022, respectively, and $1,363 million, $1,330 million, $1,417 million and $1,475 million in the first, second, third and fourth quarter of 2021, respectively.

 
 

  (8) Includes Pharmaceutical products not individually shown above.

 
 

  (9) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were $114 million, $32 million, $10 million and $10 million in the first, second, third and fourth quarter of 2022, respectively, and $56 million, $135 million and $27 million in the first, third and fourth quarter of 2021, respectively.

 
 

 

 

  

  

Media:

 

Robert Josephson
(203) 914-2372
robert.josephson@merck.com  

 

Michael Levey
(215) 872-1462
michael.levey@merck.com  

 

Investors:

 

Peter Dannenbaum
(908) 740-1037
peter.dannenbaum@merck.com  

 

Steven Graziano
(908) 740-6582
steven.graziano@merck.com  

 

News Provided by Business Wire via QuoteMedia

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Merck Announces First-Quarter 2023 Financial Results

Merck Announces First-Quarter 2023 Financial Results

 
  • First Quarter 2023 Reflected Continued Strong Underlying Performance Across Key Growth Drivers, Particularly in Oncology and Vaccines
  •  
  • Total Worldwide Sales Were $14.5 Billion, a Decrease of 9% From First Quarter 2022; Excluding LAGEVRIO, Growth Was 11%; Excluding LAGEVRIO and the Impact of Foreign Exchange, Growth Was 15%
    • KEYTRUDA Sales Grew 20% to $5.8 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24%
    •  
    • GARDASIL/GARDASIL 9 Sales Grew 35% to $2.0 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 43%
    •  
    • LAGEVRIO Sales Declined 88% to $392 Million; Excluding the Impact of Foreign Exchange, Sales Declined 87%
    •  
  •  
  • GAAP EPS Was $1.11; Non-GAAP EPS Was $1.40; GAAP and Non-GAAP EPS Include $0.52 of Charges Related to Acquisition of Imago and Collaboration and Licensing Agreement With Kelun-Biotech
  •  
  • Announced Proposed Acquisition of Prometheus Biosciences to Strengthen Immunology Pipeline
  •  
  • Presented Compelling Data From Innovative Cardiovascular Pipeline With:
    • Positive Phase 3 Results for Sotatercept
    •  
    • Positive Phase 2b Results for MK-0616; Plans to Start Phase 3 Studies in 2023
    •  
  •  
  • Advanced Oncology Research Efforts, Sharing Notable Progress for Earlier Stages of Disease in Certain Tumor Types, Including:
    • Positive Topline Results From Phase 3 KEYNOTE-671 Trial
    •  
    • Positive Detailed Results in Collaboration With Moderna From Phase 2b KEYNOTE-942/mRNA-4157-P201 Trial
    •  
  •  
  • 2023 Financial Outlook
    • Raises and Narrows Expected Full-Year 2023 Worldwide Sales Range To Be Between $57.7 Billion and $58.9 Billion, Including Negative Impact of Foreign Exchange of Approximately 2 Percentage Points; Outlook Includes Approximately $1.0 Billion of LAGEVRIO Sales
    •  
    • Lowers and Narrows Expected Full-Year 2023 GAAP EPS Range To Be Between $5.85 and $5.97, Reflecting Zetia Antitrust Litigation Settlement
    •  
    • Raises and Narrows Expected Full-Year 2023 Non-GAAP EPS Range To Be Between $6.88 and $7.00, Including Negative Impact of Foreign Exchange of Approximately 4 Percentage Points
    •  
    • Outlook Does Not Reflect Any Impact From Proposed Acquisition of Prometheus Biosciences, Which Is Expected to Close in Third Quarter 2023, and Would Result in a One-Time Charge to Both GAAP and Non-GAAP Results of Approximately $10.3 Billion or Approximately $4.00 per Share
    •  
  •  

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2023.

 

�Inspired by our commitment to bring bold science forward to address critical unmet patient needs, we began 2023 with significant advancements across our innovative pipeline," said Robert M. Davis, chairman and chief executive officer, Merck. "Our first-quarter results are a reflection of the focused execution of our science-led strategy, strong performance across our key growth drivers, continued momentum commercially and operationally, and most importantly the collective and dedicated efforts of our colleagues around the world. I'm proud of the progress we've made, and we will continue to move with speed and agility to deliver value for patients and shareholders, now and well into the future."

News Provided by Business Wire via QuoteMedia

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BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: Spectrum Pharmaceuticals, Inc. , BELLUS Health Inc , Prometheus Biosciences, Inc. , Univar Solutions Inc.

 

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

 

  Spectrum Pharmaceuticals, Inc. (Nasdaq – SPPI)  

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OTC:BCTXF

BriaCell Announces Grant to Investigator Dr. Saveri Bhattacharya at Sidney Kimmel Cancer Center – Jefferson Health

Highlights:

  • Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
  • Merck to provide KEYTRUDA® for use in the combination study.
  • The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

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As quoted in the press release:

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OTC:BCTXF

BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

  • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.);
  • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

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Various blister packs with pills and capsules in different colors and shapes.

Trump Signs Sweeping Order to Slash Drug Prices, Pressure Pharma Giants

US President Donald Trump has signed a sweeping executive order aimed at dramatically reducing prices for prescription drugs, vowing to end “foreign free-riding” on American pharmaceutical innovation.

The order directs federal agencies to pressure both drug manufacturers and wealthy foreign countries to bring their prices in line with those paid in the US, or face aggressive trade and regulatory actions.

“In case after case, our citizens pay massively higher prices than other nations pay for the same exact pill, from the same factory, effectively subsidizing socialism abroad with skyrocketing prices at home,” Trump states in the order.

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Blank pill bottle spilling a variety of pharmaceutical pills and capsules.

5 Biggest Pharmaceutical ETFs in 2025

The global pharmaceutical market reached a total value of US$1.38 trillion in 2024, according to Research and Markets, up significantly from the US$888 billion seen just over a decade earlier in 2010.

Experienced and novice investors alike may want to consider pharmaceutical exchange-traded funds (ETFs) as a way to gain exposure to the top pharma companies. Like all ETFs, pharmaceutical ETFs are a good option for those who want to trade a set of assets in the pharmaceutical industry instead of focusing solely on individual pharmaceutical stocks.

The main advantage of a pharmaceutical ETF is the fact that it can provide exposure to an overarching sector, but still trades like a stock. Pharma ETFs also offer less market volatility and lower fees and expenses.

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Invion Limited

Invion Limited

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Large pharmaceutical pill with gold dollar sign in the middle. Stock tickers and charts in the background.

Top 5 Small-cap Pharma Stocks in 2025

Today's pharmaceutical stocks are facing the challenges of government-imposed drug price caps, waning demand for COVID-19 vaccines and global stock market upheaval.

However, the industry's major underlying drivers — higher rates of cancer and chronic disease — are still at play and not expected to dissipate.

The US reigns supreme in the pharma market, both in terms of drug demand and development. In 2024, 50 novel medicines were approved by the US Food and Drug Administration (FDA), compared to 55 such approvals in 2023. Last year's FDA approvals include Eli Lilly and Company's (NYSE:LLY) Alzheimer's disease treatment Kisunla.

Big pharma largely steals the show, but some small- and mid-cap NASDAQ pharma stocks have also made gains.

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Cardiol Therapeutics (TSX:CRDL)

Cardiol Therapeutics Announces Year-End 2024 Update on Operations

Reported positive data from the Phase II MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis; results support advancing to the Phase III MAVERIC trial

Completed patient enrollment in the Phase II ARCHER trial evaluating CardiolRx™ in patients
with acute myocarditis, with topline data expected in Q2 2025

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