Merck Announces First-Quarter 2025 Financial Results
-
Total Worldwide Sales Were
$15.5 Billion , a Decrease of 2% From First Quarter 2024; Excluding the Impact of Foreign Exchange, Sales Grew 1%-
KEYTRUDA Sales Grew 4% to
$7.2 Billion ; Excluding the Impact of Foreign Exchange, Sales Grew 6% -
WINREVAIR Sales Were
$280 Million -
Animal Health Sales Grew 5% to
$1.6 Billion ; Excluding the Impact of Foreign Exchange, Sales Grew 10% -
GARDASIL/GARDASIL 9 Sales Declined 41% to
$1.3 Billion ; Excluding the Impact of Foreign Exchange, Sales Declined 40%
-
KEYTRUDA Sales Grew 4% to
-
GAAP EPS Was
$2.01 ; Non-GAAP EPS Was$2.22 -
Presented Compelling Data From a
Diverse Range of Programs, Including:- Phase 3 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa
-
Phase 3 ZENITH Trial of WINREVAIR for the Treatment of Adults With PAH (
WHO Group 1) Functional Class III or IV at High Risk of Mortality -
Phase 3 Trials Evaluating Investigational,
Once-Daily , Oral Two-Drug Regimen of Doravirine/Islatravir for the Treatment of Adults With Virologically Suppressed HIV-1 Infection
- Expanded Pipeline Through Exclusive License Agreement With Hengrui Pharma for an Investigational Oral Small Molecule Lp(a) Inhibitor; Transaction Expected to Close in Second Quarter 2025
-
Full-Year 2025 Financial Outlook
-
Continues To Expect Worldwide Sales To Be Between
$64.1 Billion and$65.6 Billion -
Now Expects Non-GAAP EPS To Be Between
$8.82 and$8.97 ; Outlook Revised to Reflect Negative Impact From Anticipated One-Time Charge of Approximately$0.06 per Share Related to License Agreement With Hengrui Pharma -
Outlook Absorbs an Estimated
$200 Million of Additional Costs for Tariffs Implemented to Date
-
Continues To Expect Worldwide Sales To Be Between
“Our company made strong progress to start the year, with increasing contributions from our newer commercialized medicines and vaccines and continued advancement of our pipeline,” said
Financial Summary
$ in millions, except EPS amounts |
First Quarter |
|||||||
2025 |
2024 |
Change |
Change Ex- Exchange |
|||||
Sales |
|
|
-2% |
1% |
||||
GAAP net income1 |
5,079 |
4,762 |
7% |
12% |
||||
Non-GAAP net income that excludes certain items1,2* |
5,611 |
5,279 |
6% |
11% |
||||
GAAP EPS |
2.01 |
1.87 |
7% |
13% |
||||
Non-GAAP EPS that excludes certain items2* |
2.22 |
2.07 |
7% |
12% |
||||
*Refer to table on page 7. |
For the first quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was
Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities.
First-Quarter Sales Performance
The following table reflects sales of the company’s top products and significant performance drivers.
|
First Quarter |
||||||||
$ in millions |
2025 |
2024 |
Change |
Change Ex-Exchange |
Commentary |
||||
Total Sales |
|
|
-2% |
1% |
|
||||
Pharmaceutical |
13,638 |
14,006 |
-3% |
-1% |
Decline driven by vaccines, virology and immunology, partially offset by growth in oncology, cardiology and diabetes. |
||||
KEYTRUDA |
7,205 |
6,947 |
4% |
6% |
Growth driven by increased global uptake in earlier-stage indications, including triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer, as well as continued strong global demand from metastatic indications, including increased uptake in bladder, endometrial and microsatellite instability-high (MSI-H) cancers, partially offset by timing of wholesaler purchases in the |
||||
GARDASIL/GARDASIL 9 |
1,327 |
2,249 |
-41% |
-40% |
Decline primarily due to lower demand in |
||||
JANUVIA/JANUMET |
796 |
670 |
19% |
21% |
Increase primarily due to higher net pricing in the |
||||
PROQUAD, M-M-R II and VARIVAX |
539 |
570 |
-5% |
-5% |
Decrease primarily reflects lower |
||||
BRIDION |
441 |
440 |
- |
1% |
Relatively flat compared with prior year, as higher demand and pricing in the |
||||
Lynparza* |
312 |
292 |
7% |
8% |
Increase primarily due to higher demand in the |
||||
WINREVAIR |
280 |
- |
- |
- |
Represents continued uptake since second-quarter 2024 launch in the |
||||
Lenvima* |
258 |
255 |
1% |
2% |
Increase primarily due to higher demand in the |
||||
VAXNEUVANCE |
230 |
219 |
5% |
7% |
Growth largely driven by higher demand in |
||||
PREVYMIS |
208 |
174 |
19% |
22% |
Growth primarily due to higher demand in the |
||||
WELIREG |
137 |
85 |
62% |
63% |
Growth primarily driven by higher demand in the |
||||
CAPVAXIVE |
107 |
- |
- |
- |
Represents continued uptake since third-quarter 2024 launch in the |
||||
LAGEVRIO |
102 |
350 |
-71% |
-69% |
Decline largely driven by lower demand in the |
||||
SIMPONI |
- |
184 |
-100% |
-100% |
Marketing rights in former |
||||
|
1,588 |
1,511 |
5% |
10% |
Growth primarily due to higher demand for Livestock products, as well as inclusion of sales from Elanco aqua business that was acquired in |
||||
Livestock |
924 |
850 |
9% |
16% |
Growth primarily driven by higher demand across all species, a benefit from timing of ruminant product sales, as well as inclusion of sales from Elanco aqua business that was acquired in |
||||
Companion Animal |
664 |
661 |
- |
3% |
Sales consistent with prior year. Sales of BRAVECTO were |
||||
Other Revenues** |
303 |
258 |
17% |
16% |
Increase primarily due to higher payments received for out-licensing arrangements and higher royalties, partially offset by lower revenue from third-party manufacturing arrangements. |
||||
*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. |
First-Quarter Expense, EPS and Related Information
The table below presents selected expense information.
$ in millions |
GAAP |
Acquisition- and Divestiture- Related Costs3 |
Restructuring C osts |
(Income) Loss From Investments in Equity Securities |
Non- GAAP2 |
|||||
First Quarter 2025 |
||||||||||
Cost of sales |
|
|
|
$ - |
|
|||||
Selling, general and administrative |
2,552 |
23 |
- |
- |
2,529 |
|||||
Research and development |
3,621 |
7 |
- |
- |
3,614 |
|||||
Restructuring costs |
69 |
- |
69 |
- |
- |
|||||
Other (income) expense, net |
(35) |
(3) |
- |
(107) |
75 |
|||||
|
|
|
|
|
|
|||||
First Quarter 2024 |
|
|
|
|
||||||
Cost of sales |
|
|
|
$- |
|
|||||
Selling, general and administrative |
2,483 |
21 |
5 |
- |
2,457 |
|||||
Research and development |
3,992 |
16 |
2 |
- |
3,974 |
|||||
Restructuring costs |
123 |
- |
123 |
- |
- |
|||||
Other (income) expense, net |
(33) |
(4) |
- |
(116) |
87 |
GAAP Expense, EPS and Related Information
Gross margin was 78.0% for the first quarter of 2025 compared with 77.6% for the first quarter of 2024. The increase was primarily due to the favorable impacts of product mix and lower restructuring costs, partially offset by higher amortization of intangible assets and the unfavorable impact of foreign exchange.
Selling, general and administrative (SG&A) expenses were
Research and development (R&D) expenses were
Other (income) expense, net, was
The effective tax rate was 13.9% for the first quarter of 2025.
GAAP EPS was
Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 82.2% for the first quarter of 2025 compared with 81.2% for the first quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by the unfavorable impact of foreign exchange.
Non-GAAP SG&A expenses were
Non-GAAP R&D expenses were
Non-GAAP other (income) expense, net, was
The non-GAAP effective tax rate was 14.2% for the first quarter of 2025.
Non-GAAP EPS was
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.
First Quarter |
||||
$ in millions, except EPS amounts |
2025 |
2024 |
||
EPS |
|
|
||
GAAP EPS |
|
|
||
Difference |
0.21 |
0.20 |
||
Non-GAAP EPS that excludes items listed below2 |
|
|
||
|
|
|
||
Net Income |
|
|
||
GAAP net income1 |
|
|
||
Difference |
532 |
517 |
||
Non-GAAP net income that excludes items listed below1,2 |
|
|
||
|
|
|
||
Excluded Items: |
|
|
||
Acquisition- and divestiture-related costs3 |
|
|
||
Restructuring costs |
105 |
246 |
||
Income from investments in equity securities |
(107) |
(116) |
||
Decrease to net income before taxes |
645 |
626 |
||
Estimated income tax (benefit) expense4 |
(113) |
(109) |
||
Decrease to net income |
|
|
Pipeline and Portfolio Highlights
In the first quarter,
In oncology, at the
Additional regulatory milestones include the
In vaccines and infectious diseases,
In cardiovascular disease, results were presented from the Phase 3 ZENITH trial evaluating WINREVAIR when added to background therapy in adults with pulmonary arterial hypertension (
Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows.
Oncology |
FDA Granted Priority Review for Merck’s Application for KEYTRUDA Plus Standard of Care as Perioperative Treatment for Resectable LA-HNSCC; Based on Results From Phase 3 KEYNOTE-689 Trial; FDA Set PDUFA Date of |
|
WELIREG Received First Conditional EC Approval for Two Indications; Based on Results From Phase 2 LITESPARK-004 and Phase 3 LITESPARK-005 Trials |
||
Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrated Noninferior Pharmacokinetics Compared to IV KEYTRUDA in Pivotal 3475A-D77 Trial; FDA Set PDUFA Date of |
||
|
||
Vaccines |
EC Approved CAPVAXIVE for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults |
|
Cardiovascular |
WINREVAIR Reduced Risk of a Composite of All-Cause Death, Lung Transplantation and Hospitalization for PAH by 76% Compared to Placebo in Phase 3 ZENITH Trial |
|
Infectious Diseases |
|
Manufacturing and
Upcoming Investor Event
Full-Year 2025 Financial Outlook
The following table summarizes the company’s full-year financial outlook.
|
Full Year 2025 |
|
|
Updated |
Prior |
Sales* |
|
|
Non-GAAP Gross margin2 |
Approximately 82% |
Approximately 82.5% |
Non-GAAPOperating expenses2** |
|
|
Non-GAAPOther (income) expense, net2 |
|
|
Non-GAAPEffective tax rate2 |
15.5% to 16.5% |
16.0% to 17.0% |
Non-GAAPEPS2*** |
|
|
Share count (assuming dilution) |
Approximately 2.51 billion |
Approximately 2.53 billion |
*The company does not have any non-GAAP adjustments to sales. |
||
**Includes |
||
***Includes expected one-time charges of approximately |
Merck’s outlook includes the impact of tariffs implemented to date by the
Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.
Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on
All participants may join the call by dialing (800) 369-3351 (
About
At
Forward-Looking Statement of
This news release of
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 pharmaceutical industry regulation and health care legislation in
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
Appendix
Generic product names are provided below.
Pharmaceutical
BRIDION
(sugammadex)
CAPVAXIVE
(Pneumococcal 21-valent Conjugate Vaccine)
GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant)
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
JANUMET(sitagliptin and metformin HCl)
JANUVIA(sitagliptin)
KEYTRUDA (pembrolizumab)
LAGEVRIO(molnupiravir)
Lenvima(lenvatinib)
Lynparza(olaparib)
M-M-R II(Measles, Mumps and Rubella Virus Vaccine Live)
PREVYMIS (letermovir)
PROQUAD(Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
SIMPONI (golimumab)
VARIVAX(Varicella Virus Vaccine Live)
VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)
WELIREG (belzutifan)
WINREVAIR (sotatercept-csrk)
BRAVECTO
(fluralaner)
____________________ |
1 Net income attributable to |
2
|
3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements. |
4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. |
|
||||||||||
CONSOLIDATED STATEMENT OF INCOME - GAAP | ||||||||||
(AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) | ||||||||||
(UNAUDITED) | ||||||||||
Table 1 | ||||||||||
GAAP | % Change | |||||||||
|
1Q25 |
|
|
1Q24 |
|
|||||
Sales |
$ |
15,529 |
|
$ |
15,775 |
|
-2% |
|||
|
||||||||||
Costs, Expenses and Other |
|
|||||||||
Cost of sales |
|
3,419 |
|
|
3,540 |
|
-3% |
|||
Selling, general and administrative |
|
2,552 |
|
|
2,483 |
|
3% |
|||
Research and development |
|
3,621 |
|
|
3,992 |
|
-9% |
|||
Restructuring costs |
|
69 |
|
|
123 |
|
-44% |
|||
Other (income) expense, net |
|
(35 |
) |
|
(33 |
) |
6% |
|||
Income Before Taxes |
|
5,903 |
|
|
5,670 |
|
4% |
|||
Income Tax Provision |
|
818 |
|
|
903 |
|
|
|||
Net Income |
|
5,085 |
|
|
4,767 |
|
7% |
|||
Less: Net Income Attributable to Noncontrolling Interests |
|
6 |
|
|
5 |
|
|
|||
Net Income Attributable to |
$ |
5,079 |
|
$ |
4,762 |
|
7% |
|||
|
||||||||||
Earnings per Common Share Assuming Dilution |
$ |
2.01 |
|
$ |
1.87 |
|
7% |
|||
Average Shares Outstanding Assuming Dilution |
|
2,531 |
|
|
2,544 |
|
||||
Tax Rate |
|
13.9 |
% |
|
15.9 |
% |
|
|||||||||||||||||||||||
FIRST QUARTER 2025 GAAP TO NON-GAAP RECONCILIATION | |||||||||||||||||||||||
(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 |
Adjustment Subtotal | Non-GAAP | ||||||||||||||||||
First Quarter | |||||||||||||||||||||||
Cost of sales |
$ |
3,419 |
|
620 |
|
36 |
|
656 |
|
$ |
2,763 |
|
|||||||||||
Selling, general and administrative |
|
2,552 |
|
23 |
|
23 |
|
|
2,529 |
|
|||||||||||||
Research and development |
|
3,621 |
|
7 |
|
7 |
|
|
3,614 |
|
|||||||||||||
Restructuring costs |
|
69 |
|
69 |
|
69 |
|
|
– |
|
|||||||||||||
Other (income) expense, net |
|
(35 |
) |
(3 |
) |
(107 |
) |
(110 |
) |
|
75 |
|
|||||||||||
Income Before Taxes |
|
5,903 |
|
(647 |
) |
(105 |
) |
107 |
|
(645 |
) |
|
6,548 |
|
|||||||||
Income Tax Provision (Benefit) |
|
818 |
|
(117 |
) |
(3 |
) |
(18 |
) |
(3 |
) |
22 |
|
(3 |
) |
(113 |
) |
|
931 |
|
|||
Net Income |
|
5,085 |
|
(530 |
) |
(87 |
) |
85 |
|
(532 |
) |
|
5,617 |
|
|||||||||
Net Income Attributable to |
|
5,079 |
|
(530 |
) |
(87 |
) |
85 |
|
(532 |
) |
|
5,611 |
|
|||||||||
Earnings per Common Share Assuming Dilution |
$ |
2.01 |
|
(0.21 |
) |
(0.03 |
) |
0.03 |
|
(0.21 |
) |
$ |
2.22 |
|
|||||||||
Tax Rate |
|
13.9 |
% |
|
14.2 |
% |
Only the line items that are affected by non-GAAP adjustments are shown. | ||||||||||||
The company 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, annual employee compensation, including senior management’s 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 reflect the amortization of intangible assets. | ||||||||||||
(2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairments 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. |
|
||||||||||
FRANCHISE / KEY PRODUCT SALES | ||||||||||
(AMOUNTS IN MILLIONS) | ||||||||||
(UNAUDITED) | ||||||||||
Table 3 | ||||||||||
2025 |
2024 |
1Q | ||||||||
1Q | 1Q | 2Q | 3Q | 4Q | Full Year | Nom % | Ex-Exch % | |||
TOTAL SALES (1) |
|
|
|
|
|
|
-2 |
1 |
||
PHARMACEUTICAL |
13,638 |
14,006 |
14,408 |
14,943 |
14,042 |
57,400 |
-3 |
-1 |
||
Oncology | ||||||||||
Keytruda |
7,205 |
6,947 |
7,270 |
7,429 |
7,836 |
29,482 |
4 |
6 |
||
Alliance Revenue – Lynparza (2) |
312 |
292 |
317 |
337 |
365 |
1,311 |
7 |
8 |
||
Alliance Revenue – Lenvima (2) |
258 |
255 |
249 |
251 |
255 |
1,010 |
1 |
2 |
||
Welireg |
137 |
85 |
126 |
139 |
160 |
509 |
62 |
63 |
||
Alliance Revenue – Reblozyl (3) |
119 |
71 |
90 |
100 |
110 |
371 |
68 |
68 |
||
Vaccines (4) | ||||||||||
Gardasil/Gardasil 9 |
1,327 |
2,249 |
2,478 |
2,306 |
1,550 |
8,583 |
-41 |
-40 |
||
ProQuad/M-M-R II/Varivax |
539 |
570 |
617 |
703 |
594 |
2,485 |
-5 |
-5 |
||
Vaxneuvance |
230 |
219 |
189 |
239 |
161 |
808 |
5 |
7 |
||
RotaTeq |
228 |
216 |
163 |
193 |
139 |
711 |
5 |
7 |
||
Capvaxive |
107 |
47 |
50 |
97 |
- |
- |
||||
Pneumovax 23 |
41 |
61 |
59 |
68 |
74 |
263 |
-33 |
-30 |
||
Hospital Acute Care | ||||||||||
Bridion |
441 |
440 |
455 |
420 |
449 |
1,764 |
- |
1 |
||
Prevymis |
208 |
174 |
188 |
208 |
215 |
785 |
19 |
22 |
||
Dificid |
83 |
73 |
92 |
96 |
79 |
340 |
13 |
13 |
||
Zerbaxa |
70 |
56 |
62 |
64 |
70 |
252 |
24 |
27 |
||
Cardiovascular | ||||||||||
Winrevair |
280 |
70 |
149 |
200 |
419 |
- |
- |
|||
Alliance Revenue - Adempas/Verquvo (5) |
106 |
98 |
106 |
102 |
109 |
415 |
8 |
8 |
||
Adempas (6) |
68 |
70 |
72 |
72 |
73 |
287 |
-3 |
1 |
||
Virology | ||||||||||
Lagevrio |
102 |
350 |
110 |
383 |
121 |
964 |
-71 |
-69 |
||
Isentress/Isentress HD |
90 |
111 |
89 |
102 |
92 |
394 |
-19 |
-17 |
||
Delstrigo |
67 |
56 |
60 |
65 |
69 |
249 |
19 |
24 |
||
Pifeltro |
45 |
42 |
39 |
42 |
40 |
163 |
7 |
7 |
||
Neuroscience | ||||||||||
Belsomra |
50 |
46 |
53 |
78 |
45 |
222 |
8 |
13 |
||
Immunology | ||||||||||
Simponi |
184 |
172 |
189 |
543 |
-100 |
-100 |
||||
Remicade |
39 |
35 |
41 |
114 |
-100 |
-100 |
||||
Diabetes (7) | ||||||||||
Januvia |
549 |
419 |
405 |
278 |
232 |
1,334 |
31 |
33 |
||
Janumet |
247 |
251 |
224 |
204 |
255 |
935 |
-2 |
2 |
||
Other Pharmaceutical (8) |
729 |
632 |
618 |
638 |
699 |
2,590 |
16 |
18 |
||
ANIMAL HEALTH |
1,588 |
1,511 |
1,482 |
1,487 |
1,397 |
5,877 |
5 |
10 |
||
Livestock |
924 |
850 |
837 |
886 |
889 |
3,462 |
9 |
16 |
||
Companion Animal |
664 |
661 |
645 |
601 |
508 |
2,415 |
- |
3 |
||
Other Revenues (9) |
303 |
258 |
222 |
227 |
185 |
891 |
17 |
16 |
Sum of quarterly amounts may not equal year-to-date amounts due to rounding. | |||||||
(1) Only select products are shown. | |||||||
(2) Alliance Revenue represents the company's share of profits, which are product sales net of cost of sales and commercialization costs. | |||||||
(3) Alliance Revenue represents royalties. | |||||||
(4) Total Vaccines sales were |
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(5) Alliance Revenue represents the company'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 the company's marketing territories. | |||||||
(7) Total Diabetes sales were |
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(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 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250424880466/en/
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