- Second-Quarter 2019 Revenues of $13.3 Billion, Reflecting 2% Operational Growth Driven by 6% Operational Growth from Pfizer Biopharmaceuticals Group
- Second-Quarter 2019 Reported Diluted EPS(1) of $0.89, Adjusted Diluted EPS(2) of $0.80
- Updated 2019 Financial Guidance Primarily to Reflect the Anticipated August 1, 2019 Formation of the Consumer Healthcare Joint Venture with GlaxoSmithKline plc(3) and the Anticipated Near-Term Completion of the Array BioPharma Inc. Acquisition
- Announces Reverse Morris Trust Transaction to Combine Upjohn and Mylan, Creating a New Global Pharmaceutical Company
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2019 and updated certain components of its 2019 financial guidance.
Results for the second quarter of 2019 and 2018(4) are summarized below.
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OVERALL RESULTS |
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($ in millions, except per share amounts) |
Second-Quarter |
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Six Months |
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2019 |
2018 |
Change |
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2019 |
2018 |
Change |
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Revenues |
$ 13,264 |
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$ 13,466 |
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(2%) |
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|
$ 26,382 |
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$ 26,373 |
|
— |
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Reported Net Income(1) |
5,046 |
|
3,872 |
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30% |
|
|
8,929 |
|
7,432 |
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20% |
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Reported Diluted EPS(1) |
0.89 |
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0.65 |
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37% |
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|
1.56 |
|
1.24 |
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26% |
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Adjusted Income(2) |
4,520 |
|
4,593 |
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(2%) |
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|
9,410 |
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9,147 |
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3% |
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Adjusted Diluted EPS(2) |
0.80 |
|
0.77 |
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4% |
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|
1.65 |
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1.52 |
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8% |
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REVENUES |
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($ in millions) |
Second-Quarter |
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Six Months |
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2019 |
2018 |
% Change |
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2019 |
2018 |
% Change |
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Total |
Oper. |
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Total |
Oper. |
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Biopharma |
$ 9,595 |
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$ 9,434 |
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2% |
6% |
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$ 18,779 |
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$ 18,315 |
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3% |
6% |
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Upjohn |
2,807 |
|
3,147 |
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(11%) |
(7%) |
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|
5,882 |
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6,267 |
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(6%) |
(3%) |
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Consumer Healthcare(3) |
862 |
|
886 |
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(3%) |
1% |
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|
1,721 |
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1,791 |
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(4%) |
(1%) |
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Total Company |
$ 13,264 |
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$ 13,466 |
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(2%) |
2% |
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$ 26,382 |
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$ 26,373 |
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— |
4% |
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Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange(5).
2019 FINANCIAL GUIDANCE(6)
Pfizer’s updated 2019 financial guidance is presented below, reflecting the following:
- Anticipated August 1, 2019 formation of the Consumer Healthcare joint venture (JV) with GlaxoSmithKline plc (GSK)(3):
– Includes revenue and expense contributions associated with Pfizer’s Consumer Healthcare business through July 31, 2019.
– Includes Pfizer’s pro rata share of the JV’s anticipated earnings, which will be recorded on a quarterly basis in Adjusted other (income)/deductions(2), from August 1, 2019 through the end of 2019. Pfizer will record its share of the JV’s anticipated earnings on a one-quarter lag; therefore, updated 2019 financial guidance for Adjusted other (income)/deductions(2) and Adjusted diluted EPS(2) now reflects Pfizer’s share of two months of the JV’s earnings that are expected to be generated in third-quarter 2019, which will be recorded by Pfizer in fourth-quarter 2019.
- Anticipated near-term completion of the Array BioPharma Inc. (Array) acquisition and completion of the Therachon Holding AG (Therachon) acquisition (see Corporate Developments section of this press release for additional details on these transactions).
A reconciliation of certain components of Pfizer’s updated 2019 financial guidance to its financial guidance provided in April 2019 is presented below. Amounts for revenues do not sum due to rounding.
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2019 Financial |
Anticipated Impact of: |
Updated 2019 |
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Pending Formation of |
Pending Array |
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Revenues ($ in billions) |
$52.0 to $54.0 |
($1.5) |
$0.1 |
$50.5 to $52.5 |
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Adjusted Diluted EPS(2) |
$2.83 to $2.93 |
($0.03) |
($0.04) |
$2.76 to $2.86 |
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Revenues |
$50.5 to $52.5 billion |
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(previously $52.0 to $54.0 billion) |
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Adjusted Cost of Sales(2) as a Percentage of Revenues |
20.1% to 21.1% |
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(previously 20.8% to 21.8%) |
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Adjusted SI&A Expenses(2) |
$13.0 to $14.0 billion |
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(previously $13.5 to $14.5 billion) |
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Adjusted R&D Expenses(2) |
$7.9 to $8.3 billion |
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(previously $7.8 to $8.3 billion) |
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Adjusted Other (Income)/Deductions(2) |
Approximately $200 million of income |
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Effective Tax Rate on Adjusted Income(2) |
Approximately 16.0% |
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Adjusted Diluted EPS(2) |
$2.76 to $2.86 |
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(previously $2.83 to $2.93) |
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Financial guidance for Adjusted diluted EPS(2) reflects $8.9 billion of share repurchases in first-quarter 2019. Dilution related to share-based employee compensation programs is currently expected to offset the reduction in shares associated with these share repurchases by approximately half.
CAPITAL ALLOCATION
- During the first six months of 2019, Pfizer returned $12.9 billion directly to shareholders, through a combination of:
– $4.0 billion of dividends, composed of dividends of $0.36 per share of common stock in each of the first and second quarters of 2019; and
– $8.9 billion of share repurchases, composed of $2.1 billion of open-market share repurchases in first-quarter 2019 and a $6.8 billion accelerated share repurchase agreement executed in February 2019.
- As of July 30, 2019, Pfizer’s remaining share repurchase authorization was $5.3 billion.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Pfizer’s Chief Executive Officer, stated, “We reported solid second-quarter 2019 financial results, with total company revenues up 2% operationally. Performance was primarily driven by 6% volume-driven operational growth in our Biopharma business, including continued growth of key brands such as Ibrance, Eliquis and Xeljanz as well as in emerging markets. This growth was partially offset primarily by the impact of generic and biosimilar competition for products that have lost marketing exclusivity, as well as the expected decline of Upjohn revenues in China.
“Today’s announcement that proposes a combination between Upjohn and Mylan N.V. (Mylan) in a Reverse Morris Trust transaction marks an important milestone in Pfizer’s evolution to be a more focused, global leader in science-based, innovative medicines that delivers breakthroughs that change patients’ lives and creates sustainable value for shareholders. The proposed transaction would unlock value by giving Pfizer shareholders majority ownership of a new company that brings together highly complementary businesses under a management team focused on leveraging scale, capabilities and geographic reach while maximizing revenue growth opportunities and free cash flow potential. Following the close of the proposed transaction, I expect Pfizer will be positioned to deliver revenue and Adjusted diluted EPS(2) growth through the mid-2020s that is among the industry leaders while continuing to allocate significant capital directly to shareholders, primarily through dividends,” Dr. Bourla concluded.
Frank D’Amelio, Chief Financial Officer and Executive Vice President, Business Operations and Global Supply, stated, “I was pleased with our second-quarter 2019 financial results, which keep us on track to deliver solid financial performance this year. We updated our 2019 financial guidance primarily for the anticipated August 1, 2019 formation of the Consumer Healthcare JV with GSK(3) and the anticipated near-term completion of the Array acquisition. Excluding the changes to guidance related to pending business development activities, our 2019 financial guidance is unchanged. Additionally, in the first half of 2019, we returned $12.9 billion directly to shareholders through dividends and share repurchases, demonstrating our commitment to returning capital to our shareholders.”
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2019 vs. Second-Quarter 2018)
Second-quarter 2019 revenues totaled $13.3 billion, a decrease of $203 million, or 2%, compared to the prior-year quarter, reflecting operational growth of $324 million, or 2%, more than offset by the unfavorable impact of foreign exchange of $527 million, or 4%.
Pfizer Biopharmaceuticals Group (Biopharma) Revenue Highlights
Second-quarter 2019 Biopharma revenues totaled $9.6 billion, up 6% operationally, primarily driven by:
- Ibrance globally, up 27% operationally, primarily driven by:
– 67% operational growth in international markets, primarily reflecting continued strong uptake in developed Europe and Japan as well as in certain emerging markets following launches; and
– 12% growth in the U.S., primarily driven by cyclin-dependent kinase (CDK) class market share growth and Ibrance’s continued CDK market share leadership in its approved metastatic breast cancer indications;
- Eliquis globally, up 26% operationally, primarily driven by continued increased adoption in non-valvular atrial fibrillation as well as oral anti-coagulant market share gains;
- Xeljanz globally, up 36% operationally, driven by:
– 103% operational growth in international markets, primarily reflecting continued uptake in the rheumatoid arthritis (RA) indication as well as from the recent launch of the ulcerative colitis (UC) indication in certain developed markets; and
– 21% growth in the U.S., reflecting volume growth from the launches of the UC and psoriatic arthritis (PsA) indications as well as continued growth in the RA indication, partially offset by higher rebating and unfavorable channel mix,
partially offset primarily by lower revenues for:
- Enbrel internationally, down 16% operationally, primarily reflecting continued biosimilar competition in most developed Europe markets as well as the unfavorable impact of timing of government purchases in certain emerging markets;
- Prevnar 13 in the U.S., down 10%, primarily reflecting lower government purchases in second-quarter 2019 for the pediatric indication as well as the continued decline in revenues for the adult indication due to a declining “catch up” opportunity compared to the prior-year quarter; and
- the Hospital business in developed markets, down 9% operationally, primarily due to the continued expected negative impact from generic competition for products that have previously lost marketing exclusivity as well as product supply shortages.
Upjohn Revenue Highlights
Second-quarter 2019 Upjohn revenues totaled $2.8 billion, down 7% operationally, primarily reflecting:
- 20% operational decline in China, primarily driven by the March 2019 implementation of a volume-based procurement program in certain cities, which had an anticipated unfavorable impact on Lipitor and Norvasc revenues. Given first-half 2019 operational growth of 13% and the outlook for the remainder of the year, revenues for Upjohn in China for the full year are expected to grow by low-to-mid-single-digits operationally; and
- 9% decline in the U.S., primarily driven by lower revenues for:
– Viagra, due to increased generic competition following Viagra’s December 2017 patent expiration; and
– Lyrica, primarily reflecting volume declines due to wholesaler destocking in advance of anticipated multi-source generic competition that was expected to begin on July 1, 2019 but instead began on July 19, 2019.
Consumer Healthcare(3) Revenue Highlights
Second-quarter 2019 Consumer Healthcare(3) revenues totaled $862 million, up 1% operationally, reflecting 4% operational growth in international markets, partially offset by a 2% decline in the U.S.
GAAP Reported(1) Income Statement Highlights
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SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(1) |
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($ in millions) (Favorable)/Unfavorable |
Second-Quarter |
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Six Months |
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2019 |
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2018 |
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% Change |
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2019 |
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2018 |
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% Change |
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Total |
Oper. |
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Total |
Oper. |
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Cost of Sales(1) |
$ |
2,576 |
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$ |
2,916 |
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(12%) |
(6%) |
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$ |
5,009 |
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$ |
5,479 |
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(9%) |
(1%) |
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Percent of Revenues |
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19.4 |
% |
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21.7 |
% |
N/A |
N/A |
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19.0 |
% |
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20.8 |
% |
N/A |
N/A |
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SI&A Expenses(1) |
|
3,511 |
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|
3,542 |
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(1%) |
2% |
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|
6,850 |
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|
6,954 |
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(1%) |
1% |
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R&D Expenses(1) |
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1,842 |
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|
1,797 |
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2% |
3% |
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|
3,544 |
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|
3,540 |
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— |
1% |
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Total |
$ |
7,929 |
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$ |
8,255 |
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(4%) |
— |
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$ |
15,403 |
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$ |
15,973 |
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(4%) |
— |
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Other (Income)/Deductions––net(1) |
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$126 |
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($551 |
) |
* |
* |
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$218 |
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($728 |
) |
* |
* |
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Effective Tax Rate on Reported Income(1) |
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(22.1 |
%) |
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14.3 |
% |
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(5.7 |
%) |
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13.9 |
% |
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* Indicates calculation not meaningful.
Pfizer recorded other deductions––net(1) in second-quarter 2019 compared with other income––net(1) in the prior-year quarter, primarily driven by:
- lower net gains on equity securities;
- lower income from collaborations, out-licensing and sale of compound/product rights;
- higher business and legal entity alignment costs;
- higher charges for certain legal matters; and
- higher net interest expense,
partially offset primarily by:
- higher royalty-related income.
Pfizer’s effective tax rate on Reported income(1) for second-quarter 2019 compared to the prior-year period was favorably impacted primarily by a tax benefit related to the settlement of a U.S. Internal Revenue Service audit for multiple tax years.
Adjusted(2) Income Statement Highlights
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SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2) |
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($ in millions) (Favorable)/Unfavorable |
Second-Quarter |
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Six Months |
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2019 |
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2018 |
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% Change |
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2019 |
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2018 |
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% Change |
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Total |
Oper. |
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Total |
Oper. |
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Adjusted Cost of Sales(2) |
$ |
2,556 |
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$ |
2,876 |
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(11%) |
(5%) |
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$ |
4,971 |
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$ |
5,413 |
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(8%) |
(1%) |
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Percent of Revenues |
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19.3 |
% |
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21.4 |
% |
N/A |
N/A |
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18.8 |
% |
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20.5 |
% |
N/A |
N/A |
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Adjusted SI&A Expenses(2) |
|
3,464 |
|
|
3,507 |
|
(1%) |
2% |
|
|
|
6,775 |
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|
6,793 |
|
— |
3% |
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Adjusted R&D Expenses(2) |
|
1,825 |
|
|
1,789 |
|
2% |
3% |
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|
3,518 |
|
|
3,528 |
|
— |
1% |
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Total |
$ |
7,845 |
|
$ |
8,173 |
|
(4%) |
— |
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$ |
15,264 |
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$ |
15,733 |
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(3%) |
1% |
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Adjusted Other (Income)/Deductions––net(2) |
($100 |
) |
($262 |
) |
(62%) |
(64%) |
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|
($235 |
) |
($466 |
) |
(50%) |
(53%) |
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Effective Tax Rate on Adjusted Income(2) |
|
16.9 |
% |
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16.1 |
% |
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16.0 |
% |
|
16.4 |
% |
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Second-quarter 2019 diluted weighted-average shares outstanding used to calculate Reported(1) and Adjusted(2) diluted EPS declined by 280 million shares compared to the prior-year quarter primarily due to Pfizer’s ongoing share repurchase program, reflecting the impact of share repurchases during 2018 and in first-quarter 2019, partially offset by dilution related to share-based employee compensation programs.
A full reconciliation of Reported(1) to Adjusted(2) financial measures and associated footnotes can be found starting on page 21 of the press release located at the hyperlink below.
RECENT NOTABLE DEVELOPMENTS (Since April 30, 2019)
Product Developments
- Bavencio (avelumab) — In May 2019, Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, and Pfizer announced that the U.S. Food and Drug Administration (FDA) approved Bavencio in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
- Eucrisa (crisaborole) — In July 2019, Pfizer announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience. Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.
- Lorbrena/Lorviqua (lorlatinib) — In May 2019, Pfizer announced that the European Commission (EC) granted conditional marketing authorization for Lorviqua (available in the U.S., Canada and Japan under the brand name Lorbrena), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.
- Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) — In June 2019, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) voted to revise the pneumococcal vaccination guidelines and recommend Prevnar 13 based on shared clinical decision making for adults 65 years or older who do not have an immunocompromising condition and who have not previously received Prevnar 13. This represents a change from the current CDC recommendation for routine use among all immunocompetent adults aged 65 years and older. This new recommendation means the decision to vaccinate should be made at the individual level between health care providers and their patients. Once the ACIP recommendation has been reviewed and approved by the CDC Director and the U.S. Department of Health and Human Services, it would be published in CDC’s Morbidity and Mortality Weekly Report. Prevnar 13 continues to be routinely recommended for adults with immunocompromising conditions.
- Ruxience (rituximab-pvvr) — In July 2019, Pfizer announced that the FDA approved Ruxience, a biosimilar to Rituxan®(7) (rituximab), for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.
- Talzenna (talazoparib) — In June 2019, Pfizer announced that the EC approved Talzenna as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations, who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. This approval follows the medicine’s approval by the FDA in October 2018.
- Vyndaqel/Vyndamax (tafamidis) — In May 2019, Pfizer announced that the FDA approved both Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Vyndaqel and Vyndamax are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM. The recommended dosage is either Vyndaqel 80 mg orally once-daily, taken as four 20 mg capsules, or Vyndamax 61 mg orally once-daily, taken as a single capsule. Vyndamax was developed for patient convenience; Vyndaqel and Vyndamax are not substitutable on a per milligram basis.
- Xeljanz (tofacitinib)
– In July 2019, the FDA updated the U.S. prescribing information for Xeljanz to include two additional boxed warnings as well as changes to the indication and dosing for UC. These updates were based on the FDA’s review of data from the post-marketing requirement RA study A3921133.
– In June 2019, Pfizer announced positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active RA. Patients who achieved low disease activity with Xeljanz extended release 11 mg once daily (Xeljanz XR) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of Xeljanz XR as monotherapy after MTX withdrawal compared with Xeljanz XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with Xeljanz XR compared to Xeljanz XR plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results were presented during a late-breaking oral session at the Annual European Congress of Rheumatology.
– In May 2019, Pfizer announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued recommendations limiting the use of Xeljanz 10 mg twice daily (BID) in patients at increased risk of pulmonary embolism (PE) in the European Union (EU). These recommendations have been incorporated in updated EU product labeling for Xeljanz, which is provisional, while PRAC undertakes a review of all available evidence on the safety and efficacy of Xeljanz. The review is a result of the observation of increased risk of PE with tofacitinib 10 mg BID in an ongoing FDA post-marketing requirement study in individuals with RA who had one or more underlying cardiovascular risk factors. Specifically, it is recommended that tofacitinib 10 mg BID should not be prescribed to patients who are at high risk of PE. Additionally, patients who are already taking 10 mg BID and are at high risk of PE should be switched to alternative treatments. In the EU, tofacitinib 10 mg BID is an approved dose for patients with UC but it is not an approved dose for patients with moderate to severe RA nor for those with active PsA. The review is being carried out by PRAC, the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations at the request of the EC. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use. The final stage of the review procedure is the adoption by the EC of a legally binding decision applicable in all EU Member States.
- Zirabev (bevacizumab-bvzr) — In June 2019, Pfizer announced that the FDA approved Zirabev, a biosimilar to Avastin®(8), for the treatment of five types of cancer: metastatic colorectal cancer (CRC); unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer.
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
- Abrocitinib (PF-04965842) — In May 2019, Pfizer announced positive top-line results from a Phase 3 pivotal study (JADE MONO-1) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe AD. JADE MONO-1 was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of abrocitinib monotherapy over 12 weeks. Top-line results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo. In addition, the results demonstrate response to treatment for a statistically significant number of patients during the first two to four weeks following first dose. Safety results show that both doses of abrocitinib were well-tolerated, and there were no unexpected safety events. No cases of major adverse cardiovascular events, malignancies, or venous thromboembolism, including deep vein thrombosis and PE, were observed in the JADE MONO-1 study. The discontinuation rates due to an adverse event were low in each treatment arm (5.8% and 5.8% in 100 mg and 200 mg, respectively) compared to placebo (9.1%).
- Glasdegib (PF-
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