Alexion reported strong financial results for Q3 2019, with total net product sales increasing 23% year-over-year to $1.263 billion. Sales of key drugs SOLIRIS, STRENSIQ, and KANUMA all increased compared to Q3 2018. R&D and SG&A expenses increased year-over-year as the company continues to invest in its pipeline. GAAP and non-GAAP EPS both increased compared to the prior year period. The CEO highlighted the company's continued execution across its portfolio and pipeline expansion through business development deals.
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November Edition 2019
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Table of Contents
1. Financial, M & A Updates...................................................................................................................................1
2. Solution Updates................................................................................................................................................50
3. Rewards and Recognition Updates..................................................................................................................71
4. Partnership Ecosystem Updates.......................................................................................................................78
5. Event Updates.....................................................................................................................................................94
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Financial, M & A
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AbbVie (USA) Reports Third-Quarter 2019 Financial Results
• Worldwide net revenues were $8.479 billion, an increase of 3.0 percent on a reported basis, or 3.5 percent operationally.
• Global HUMIRA net revenues of $4.936 billion decreased 3.7 percent on a reported basis, or 3.2 percent operationally. U.S.
HUMIRA net revenues were $3.887 billion, an increase of 9.6 percent. Internationally, HUMIRA net revenues were $1.049
billion, a decrease of 33.5 percent on a reported basis, or 31.8 percent operationally, due to biosimilar competition.
• Global net revenues from the hematologic oncology portfolio were $1.478 billion, an increase of 38.3 percent on a reported
basis, or 38.5 percent operationally. Global IMBRUVICA net revenues were $1.257 billion, an increase of 29.3 percent, with
U.S. net revenues of $1.042 billion and international profit sharing of $215 million. Global VENCLEXTA net revenues were
$221 million.
• Global HCV net revenues were $698 million, a decrease of 19.0 percent on a reported basis, or 18.6 percent operationally. In
the U.S., HCV net revenues of $368 million decreased 17.0 percent in the quarter. Internationally, HCV net revenues of $330
million decreased 21.2 percent on a reported basis, or 20.4 percent operationally.
• On a GAAP basis, the gross margin ratio in the third quarter was 77.4 percent. The adjusted gross margin ratio was 82.0
percent.
• On a GAAP basis, selling, general and administrative expense was 19.5 percent of net revenues. The adjusted SG&A expense
was 19.1 percent of net revenues.
• On a GAAP basis, research and development expense was 26.9 percent of net revenues. The adjusted R&D expense was 14.5
percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
• On a GAAP basis, the operating margin in the third quarter was 30.9 percent. The adjusted operating margin was 48.4 percent.
• On a GAAP basis, net interest expense was $420 million. The adjusted net interest expense was $288 million. On a GAAP
basis, the tax rate in the quarter was 5.9 percent. The adjusted tax rate was 8.8 percent.
• Diluted EPS in the third quarter was $1.26 on a GAAP basis, inclusive of an impairment charge related to intangible assets
acquired as part of the 2016 acquisition of Stemcentrx, Inc. Adjusted diluted EPS, excluding specified items, was $2.33.
Executive Commentary
"Strong performance from our Immunology and Hematologic Oncology portfolios led our growth this quarter. We are
also making excellent progress with several key strategic priorities, including the recent launch of our two new
immunology therapies - Rinvoq and Skyrizi - both of which are off to an impressive start, as well as continued progress
toward the completion of our planned acquisition of Allergan," said Chairman and chief executive officer, AbbVie.
"Based on the continued momentum of our portfolio, we are once again raising our full year 2019 EPS guidance range
and increasing our dividend."
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Abiomed(USA) Announces Q2 FY 2020 Results
• U.S. revenue totaled $172.0 million, an increase of 9% compared to revenue of $158.2 million during the same period of fiscal 2019 with U.S. patient usage of Impella heart pumps
up 14%. In the second quarter, we opened 62 new sites, compared to 135 sites in the prior year, which impacted our U.S. growth rate by $3 million in revenue, or approximately two
points of growth.
• Outside the U.S., revenue totaled $33.0 million, an increase of 40% compared to revenue of $23.5 million during the same period of fiscal 2019. Specifically, Japan revenue was $9.6
million in the quarter, up 135% compared to the same period of fiscal 2019.
• Gross margin was 83.0% compared to 83.6% during the same period of fiscal 2019.
• Operating income was $60.2 million, or 29.4% operating margin compared to $50.3 million, or 27.7% operating margin in the same period of fiscal 2019.
• GAAP net income was $13.1 million, or $0.28 per diluted share, which includes a $34.5 million, or $0.75 per share, unrealized loss from our investment in Shockwave. This compared
to GAAP net income of $50.1 million or $1.09 per diluted share for the prior fiscal year, which benefited from $12.9 million, or $0.28 per share, of excess tax benefits.
• The company generated operating cash flow of $74.3 million in the second quarter and $138.9 million year to date, an increase of 30% versus prior year. As of September 30, 2019,
the company had $551.3 million of cash and marketable securities and maintains no debt.
• On September 23, the company announced that the highest court in Germany, the Federal Court of Justice, ruled in favor of Abiomed in a patent challenge, specifically around the
pigtail and design for insertion, filed by Thoratec in 2015, validating the strengths of Abiomed’sImpella-related patents. Abiomed has invested more than $500 million and 20 years of
research and development for Impella and owns a robust world-wide portfolio of 715 patents and 622 patents pending, covering all aspects of its existing and future products.
• On September 25, the company announced that the Impella 5.5 with SmartAssist received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and
efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump designed for heart
surgeons, implanted via axillary artery or direct to the aorta.
• On September 26, the company announced the results of PROTECT III, the ongoing, prospective, single-arm FDApost-approval study for the PMAapproval of Impella 2.5 and Impella
CP in high-risk PCI. PROTECT III follows the PROTECT II Randomized Controlled Trial (RCT). The findings of this interim analysis on 898 patients demonstrates a reduction in the
primary endpoint of death, stroke, myocardial infarction and repeat procedures at 90 days with Impella-supported Protected PCI, compared to PROTECT II.
• On September 27, the company announced that data presented from the National Cardiogenic Shock Initiative Study (NCSI) on 250 consecutive AMI cardiogenic shock patients from
49 sites demonstrates 72% survival at discharge with 98% native heart recovery. The patients were treated with the NCSI protocol, which includes placing Abiomed’sImpella heart pump
before revascularization via percutaneous coronary intervention (PCI). Investigators also now plan to institute new escalation protocols that will be applied in the cath lab immediately
after Impella-supported PCI in order to further increase patient survival and native heart recovery.
• On October 7, the company announced that the 1,000th patient has been treated with the Impella heart pump in Japan. Procedural outcomes data, available on the first 580 Japanese
cases, demonstrates improvements in AMI cardiogenic shock and myocarditis survival rates during the procedure, compared to traditional therapies. The protocols used to introduce
Impella in Japan were developed based on best practices learned from the experience treating patients in Europe and the United States, including the National Cardiogenic Shock
Initiative, the Impella Quality (IQ) Database and the cVAD Study.
• On October 25, the company announced that the FDA Post Approval Study demonstrates timely identification of right heart failure and early use of Impella RP leads to higher survival.
When physicians followed the FDA’s approved protocol for Impella RP use they achieved 72% patient survival and 88% native heart recovery. These results, from the Impella RP’s
post-approval study, match the survival rate in the Impella RP’s pre-approval study.
• The company announces the first U.S. patients treated with Impella 5.5 with SmartAssist. The first 10 patients were treated at the Cleveland Clinic, Hackensack Meridian Health and
Cedars-Sinai Medical Center in Los Angeles. The Impella 5.5 with SmartAssist is being introduced in the U.S. through a controlled rollout at hospitals with established heart recovery
protocols.
Executive Commentary
“We are pleased that this quarter demonstrated our ability to leverage best practices and support strategies to improve clinical outcomes overall for high risk PCI, cardiogenic
shock and right heart failure,” said Chairman, President and Chief Executive Officer, Abiomed, Inc. “We have made progress on our key initiatives in the quarter, but we still
have more work to do. Our innovation and ability to improve clinical outcomes remains the driver for Impella adoption through a function of training, data and time.”
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CVS Health (USA) Reports Third Quarter Results
• Total revenues and adjusted revenueincreased 36.5% and 37.1%, respectively, for the three months
ended September 30, 2019 compared to the prior year.
• Operating expenses and adjusted operating expensesincreased 72.8% and 61.5%, respectively, for
the three months ended September 30, 2019 compared to the prior year. The increase in both operating
expenses and adjusted operating expenses was primarily driven by the impact of the Aetna
Acquisition.
• Operating income and adjusted operating income increased 13.8% and 48.9%, respectively, for the
three months ended September 30, 2019 compared to the prior year. The increase in both operating
income and adjusted operating income was primarily due to the impact of the Aetna Acquisition as
well as increased claims volume and improved purchasing economics in the Pharmacy Services
segment. These increases were partially offset by continued reimbursement pressure in the
Retail/LTC segment and continued price compression in the Pharmacy Services segment.
• Net income increased 10.0% for the three months ended September 30, 2019 compared to the prior
year primarily due to the higher operating income described above, partially offset by (i) higher
interest expense primarily due to the assumption of Aetna’s debt as of the Aetna Acquisition Date, (ii)
the loss on early extinguishment of debt of $79 million related to the Company’s repayment of $4.0
billion of its outstanding senior notes pursuant to its tender offers for such senior notes in August 2019
and (iii) higher income tax expense associated with the increase in pre-tax income.
• The effective income tax rate was 28.3% for the three months ended September 30, 2019 compared
to 26.8% for the three months ended September 30, 2018. The increase in the effective income tax rate
was primarily due to the impact of the sale of Onofre in the three months ended September 30, 2019.
Executive Commentary
President and Chief Executive Officer stated, “Our third quarter results build on the positive
momentum we have seen across the company since the beginning of the year. All of our core
businesses performed in line with or above expectations, reflecting strong operational execution.
As a result, we delivered strong growth and generated robust operating cash flow, which enabled
us to continue to delever while returning capital to our shareholders.”
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Alexion (USA) Reports Third Quarter 2019 Results
• Total net product sales were $1,263.1 million in the third quarter of 2019, compared to $1,026.5 million
in the third quarter of 2018.
• SOLIRIS® (eculizumab) net product sales were $990.5 million, compared to $888.0 million in the third
quarter of 2018, representing a 12 percent increase. SOLIRIS volume increased 11 percent year-over-year.
• ULTOMIRIS® (ravulizumab-cwvz) net product sales were $89.9 million in the third quarter of 2019.
• STRENSIQ® (asfotase alfa) net product sales were $154.3 million, compared to $113.2 million in the
third quarter of 2018, representing a 36 percent increase. STRENSIQ volume increased 36 percent
year-over-year.
• KANUMA® (sebelipase alfa) net product sales were $28.4 million, compared to $25.3 million in the
third quarter of 2018, representing a 12 percent increase. KANUMA volume increased 16 percent
year-over-year.
• GAAP cost of sales was $95.2 million, compared to $90.6 million in the third quarter of 2018. Non-GAAP
cost of sales was $91.8 million, compared to $87.3 million in the third quarter of 2018.
• GAAP R&D expense was $232.9 million, compared to $174.8 million in the third quarter of 2018.
Non-GAAP R&D expense was $186.1 million, compared to $162.3 million in the third quarter of 2018.
• GAAP SG&A expense was $299.3 million, compared to $258.7 million in the third quarter of 2018.
Non-GAAP SG&A expense was $260.4 million, compared to $224.5 million in the third quarter of 2018.
• GAAP income tax expense was $67.9 million, compared to $11.2 million in the third quarter of 2018.
Non-GAAP income tax expense was $82.5 million, compared to $75.8 million in the third quarter of 2018.
• GAAP diluted EPS was $2.08, compared to $1.47 in the third quarter of 2018. Non-GAAP diluted EPS
was $2.79, compared to $2.02 in the third quarter of 2018.
Executive Commentary
"With consistent and strong execution, we have delivered another record performance in the third
quarter, building on our momentum from the first half of 2019. Our teams continued to demonstrate
launch excellence across the globe, with very rapid starts to the German and Japanese ULTOMIRIS
PNH launches, where conversion is progressing ahead of the best-in-class U.S. launch at the same
time points, as well as a strong start to the SOLIRIS NMOSD launch in the U.S.," said Chief Executive
Officer of Alexion. "We also continued to expand our portfolio with two additional approvals -
ULTOMIRIS for atypical HUS in the U.S. and SOLIRIS for NMOSD in the EU - and three new
business development transactions that further diversify our pipeline, including an agreement to
acquire Achillion. By continuing to deliver on the ambitious transformation plan we laid out
two-and-a-half years ago, we have successfully established a strong foundation for the future and look
forward to building on this progress as we advance our mission of delivering life-changing therapies
to people with rare diseases."
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Align Technology (USA) Announces Third Quarter 2019
Financial Results
• Reported financial results for the third quarter ended September 30, 2019. Q3’19
Invisalign volume was 385.4 thousand cases, up 20.7% year-over-year.
• For the Americas and International regions, Q3’19 Invisalign volume was up
13.0% and 32.1% year-over-year, respectively.
• Q3’19 Invisalign volume for teenage patients was 129.6 thousand cases, up 31.5%
year-over-year.
• Q3’19 total revenues were $607.3 million, up 20.2% year-over-year, and Q3’19
scanner and services revenues were $91.1 million, up 16.5% year-over-year.
• Q3’19 operating income was $127.2 million or operating margin of 20.9%. Q3’19
net profit was $102.5 million, or $1.28 per diluted EPS.
• Q3’19 operating expenses included a $6.8 million benefit from the settlement of
our Invisalign Store leases, which increased Q3’19 operating margin by
approximately 1.1 points and benefited diluted EPS by $0.06. This compares to
Q2’19 operating income of $176.5 million or operating margin of 29.4% and Q2’19
net profit of $147.1 million, or $1.83 per diluted EPS. Q2’19 operating expenses
included a $51.0 million benefit from the ClearCorrect settlement with Straumann,
which increased Q2’19 operating margin by approximately 8 points and benefited
diluted EPS by $0.57.
Executive Commentary
Commenting on Align’s third quarter results, Align Technology President and
CEOsaid, “I’m pleased to report revenues, volume, and earnings above our third
quarter outlook driven by better than expected volume across the Invisalign
portfolio in Asia Pacific and Latin America, reflecting record highs for both
regions and improving trends in the North American orthodontic channel.
Notwithstanding EMEA summer seasonality, we saw continued adoption from
teens and especially younger patients using Invisalign First across the board. Q3
Invisalign volumes were up 20.7% year-over-year driven by growth across the
product portfolio, as well as expansion of our customer base, which increased by
6,000 new Invisalign doctors for a total of 63,000 active doctors worldwide. The
iTero scanner and services business was up 16.5% year over year reflecting
continue growth across each region, and down sequentially as expected coming
off a record second quarter.”
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Allergan (Ireland) Reports Third Quarter 2019 Financial Results
• GAAP operating loss in the third quarter of 2019 was $596.6 million compared to GAAP operating income of
$257.5 million in the prior year quarter.
• Non-GAAP operating income in the third quarter of 2019 was $1.76 billion, a decrease of 7.7 percent versus the
prior year quarter, partially impacted by divestitures, products that lost or are at risk of losing exclusivity and an
increase in operating expenses.
• GAAP cash flow from operations for the third quarter of 2019 totaled $2.92 billion. Cash flow from operations
in the third quarter includes a one-time tax refund of $1.6 billion of capital gains taxes previously paid and
attributable to tax losses recorded in prior periods.
• Total GAAP Selling, General and Administrative (SG&A) Expense was $1.99 billion for the third quarter of
2019, compared to $1.04 billion in the prior year quarter.
• Total non-GAAP SG&A expense was $1.18 billion for the third quarter of 2019, an increase of 14.3 percent
from the prior year quarter, primarily related to an increase in spending to support key products and new product
launches.
• GAAP R&D investment for the third quarter of 2019 was $474.5 million, compared to $424.2 million in the
third quarter of 2018.
• Non-GAAP R&D investment for the third quarter of 2019 was $448.9 million, an increase of 14.0 percent
compared to the prior year quarter, due to increased direct project spend to support pipeline advancement and
new product launches.
• Amortization expense for the third quarter of 2019 was $1.54 billion, compared to $1.59 billion in the third
quarter of 2018.
• The Company's GAAP tax rate was -2.4 percent in the third quarter of 2019.
• The Company's non-GAAP adjusted tax rate was 11.2 percent in the third quarter of 2019. As of September 30,
2019, Allergan had cash and marketable securities of $4.56 billion and outstanding indebtedness of $22.5 billion.
Executive Commentary
"The third quarter 2019 results demonstrate our commitment to continued strong operational performance.
The core business has grown and has been bolstered by significant pipeline progress, with three new
molecular entities currently under regulatory review," saidChairman and CEO of Allergan. "VRAYLAR®,
BOTOX® Cosmetic, JUVÉDERM®, BOTOX® Therapeutic, OZURDEX® and Lo LOESTRIN® continue
to lead the way, with VRAYLAR® growing 70 percent and U.S. BOTOX® Cosmetic growing 10 percent
in the third quarter from the prior year."
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Amgen (USA) Reports Third Quarter 2019 Financial Results
• Total revenues decreased 3% to $5.7 billion in comparison to the third
quarter of 2018, reflecting the impact of biosimilar and generic competition
against key products.
• GAAP earnings per share (EPS) increased 14% to $3.27 benefited by lower
weighted-average shares outstanding and higher operating income.
• GAAP operating income increased 7% to $2.5 billion and GAAP operating
margin increased 3.1 percentage points to 45.3%.
• Non-GAAP EPS decreased 1% to $3.66 as a result of lower revenue, offset
partially by lower weighted-average shares outstanding.
• Non-GAAP operating income decreased 6% to $2.8 billion and non-GAAP
operating margin decreased 2.8 percentage points to 51.1%.
• The Company generated $3.2 billion of free cash flow in the third quarter of
2019 versus $3.1 billion in the third quarter of 2018.
• 2019 total revenues guidance revised to $22.8-$23.0 billion; EPS guidance
to $12.50-$12.80 on a GAAP basis and $14.20-$14.45 on a non-GAAP basis.
This guidance excludes the impact of the Otezla® (apremilast) acquisition.
• The Company expects the Otezla acquisition to close before the end of the
fourth quarter.
Executive Commentary
"Amgen continues to execute well in a dynamic environment, with many
of our innovative medicines delivering double-digit, volume-driven
growth, complemented by the strong performance of our recently launched
biosimilar products," said Chairman and chief executive officer. "We
continue to advance numerous first-in-class medicines in our pipeline,
while also pursuing external opportunities that will contribute to our
long-term growth, such as our pending acquisition of Otezla."
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Anthem (USA) Reports Third Quarter 2019 Results
• Membership: Medical enrollmenttotaled approximately 41.0 million members at September 30, 2019, an increase of 1.1 million, or 2.7 percent, from
September 30, 2018. Total fully insured enrollment grew by 968 thousand lives, or 6.6 percent, and self-funded enrollment grew by 115 thousand lives, or
0.5 percent. Government Business enrollment increased by 864 thousand lives as the Company experienced growth in Medicaid and Medicare. Commercial
& Specialty Business enrollment increased by 219 thousand lives driven by growth in the National and Individual businesses, partially offset by a decline
in Local Group enrollment.
• Medical enrollment increased sequentially by 132 thousand lives during the third quarter of 2019, reflecting growth in Medicaid and Medicare, partially
offset by declines in Commercial & Specialty Business enrollment.
• Operating Revenue: Operating revenue was $26.4 billion in the third quarter of 2019, an increase of $3.5 billion, or 15.1 percent, versus the prior year
quarter. The increase in operating revenue reflected membership growth across our businesses, premium rate increases to cover overall cost trends, and
growth in our value-added services, including our pharmacy and integrated health offerings. The increase was partially offset by the one year waiver of the
health insurance tax in 2019.
• Benefit Expense Ratio: The benefit expense ratio was 87.2 percent in the third quarter of 2019, an increase of 240 basis points from 84.8 percent in the
prior year quarter. The increase, as expected, was primarily driven by the one year waiver of the health insurance tax in 2019.
• Medical claims reserves established at December 31, 2018 developed in line with the Company’s expectation during the first nine months of 2019.
• Medical Cost Trend: For the full year 2019, the Company continues to expect underlying Local Group medical cost trend will be in the range of 6.0% +/-
50 basis points
• Days in Claims Payable: Days in Claims Payable was 39.8 days as of September 30, 2019, an increase of 0.7 days from 39.1 days as of June 30, 2019.
• SG&A Expense Ratio: The SG&A expense ratio was 12.9 percent in the third quarter of 2019, a decrease of 250 basis points from 15.4 percent in the third
quarter of 2018. The decrease, as expected, was primarily driven by growth in operating revenue and the one year waiver of the health insurance tax in 2019.
• Operating Cash Flow: Operating cash flow in the third quarter of 2019 was $1.7 billion, or 1.4 times net income, and an increase of $1.1 billion compared
to the third quarter of 2018. Operating cash flow was $4.7 billion, or 1.2 times net income for the nine months ending September 30, 2019.
• Share Repurchase Program: During the third quarter of 2019, the Company repurchased 2.4 million shares of its common stock for $644 million, or a
weighted average price of $266.52. As of September 30, 2019, the Company had approximately $4.1 billion of Board-approved share repurchase
authorization remaining.
• Cash Dividend: During the third quarter of 2019, the Company paid a quarterly dividend of $0.80 per share, representing a distribution of cash totaling
$204 million.
• On October 22, 2019, the Audit Committee declared a fourth quarter 2019 dividend to shareholders of $0.80 per share. On an annualized basis, this equates
to a dividend of $3.20 per share. The fourth quarter dividend is payable on December 20, 2019 to shareholders of record at the close of business on December
5, 2019.
• Investment Portfolio & Capital Position: During the third quarter of 2019, the Company recorded net realized gains of $1 million and other-than-temporary
impairment losses totaling $13 million. During the third quarter of 2018, the Company recorded net realized gains of $27 million and other-than-temporary
impairment losses totaling $6 million.
• As of September 30, 2019, the Company’s net unrealized gain position in the investment portfolio was $711 million, consisting of fixed maturity securities.
As of September 30, 2019 cash and investments at the parent company totaled approximately $3.0 billion.
Executive Commentary
"Anthem's third quarter results showed continued membership growth – together with strong operating revenue growth – giving us great momentum
as we head into 2020," said President and CEO. I am pleased with our success to date as we remain committed to delivering a simpler, more affordable
and more personalized healthcare experience for those we serve."
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Baxter (USA) Reports Preliminary Third Quarter 2019
Operating Results
• Third quarter net revenue of $2.85 billion increased 3% on a reported
basis and 5% on both a constant currency and operational basis1
• Sales in the U.S. totaled $1.2 billion and International sales totaled $1.6
billion. All Baxter geographic regions contributed to positive sales
performance in the quarter. Sales in the Americas were $1.5 billion, sales
in Europe, Middle East and Africa (EMEA) were $730 million, and sales
in Asia Pacific (APAC) were $587 million.
• Third quarter GAAP operating income totaled $503 million or 17.6%
of sales; adjusted operating income totaled $555 million or 19.5% of
sales
• Performance driven by strong top-line results across all global
businesses and regions as well as continued execution on business
transformation initiatives
• Baxter expects fourth quarter 2019 sales growth of 3-4% on a reported
basis and approximately 5% on both a constant currency and operational
basis
• The Company announces internal investigation of misstatements in
previously reported non-operating income related to foreign exchange
gains and losses
Executive Commentary
“Our strong preliminary operating results reflect the positive impact
of Baxter’s ongoing transformation, commitment to innovation and
continued operational excellence,” said Chairman and chief
executive officer. “While the Company is working diligently and
expeditiously to address the non-operating related accounting issue,
Baxter’s 50,000 employees remain intently focused on our Mission to
Save and Sustain lives as well as executing on our strategy to deliver
top quartile performance for all stakeholders.”
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Baxter (USA) Reports Preliminary Third Quarter 2019
Operating Results
• Total Net Product Revenues for the third of quarter 2019 increased to $450.9
million, compared to $386.3 million for the third quarter of 2018.
• increased gross profits of $51.3 million driven by increased product sales
• GAAP Net Income (Loss) Guidance for the full-year 2019 was narrowed to the
low-end of the previously reported range to a loss of between $45 million to $65
million, reflecting continued expense management and strong net product sales.
• Non-GAAP Income for the third quarter of 2019 increased $17.4 million, or
29%, to $78.1 million, compared to $60.7 million for the same period in 2018.
The increase in Non-GAAP Income for the quarter, compared to the same period
in 2018, was attributed to higher gross profit and driven by R&D expense
management, partially offset by higher SG&A expense. The increase in
Non-GAAP Income for the third quarter of 2019 resulted in narrowed full-year
Non-GAAP income guidance to the high-end of the previously reported the range
to between $150 million and $170 million.
• As of September 30, 2019, BioMarin had cash, cash equivalents and
investments totaling approximately $1.2 billion, as compared to $1.3 billion on
December 31, 2018.
Executive Commentary
Commenting on third quarter results, Chairman and Chief Executive Officer
of BioMarin, said, "BioMarin is entering a stage that I believe will bring
significant growth as we get closer to submitting marketing applications for
valoctocogeneroxaparvovec for severe hemophilia A and a pivotal data
read-out for vosoritide for children with achondroplasia. These potential new
products, combined with our strong base business and continued financial
discipline, position us for significant growth and expansion beginning in the
very near future. Later this quarter, both the U.S. and European marketing
applications for valoctocogeneroxaparvovec for severe hemophilia A will be
submitted. If the applications are approved, we could potentially be launching
the first approved gene therapy product in hemophilia A in the second half of
2020. We are also encouraged by the recent recommendation by the European
Medicines Agency (EMA) to grant our request for accelerated assessment of
valoctocogeneroxaparvovec for severe hemophilia A. We are very pleased
with the level of engagement we have had with global health authorities, as it
aligns with our belief that gene therapy will be the next wave of innovation
for treating people with severe hemophilia A."
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Bio-Rad (USA) Reports Third-Quarter 2019 Financial Results
• Third-quarter 2019 net sales were $560.6 million, an increase of 2.8 percent compared to $545.1 million
reported for the third quarter of 2018. On a currency-neutral basis, quarterly sales increased 4.5 percent compared
to the same period in 2018, reflecting growth across the business. Third-quarter gross margin was 54.8 percent
compared to 52.6 percent during the third quarter in 2018.
• Life Science segment net sales for the third quarter were $215.7 million, an increase of 4.5 percent compared
to the same period in 2018. On a currency-neutral basis, Life Science segment sales increased by 5.7 percent
compared to the same quarter in 2018. Currency-neutral sales reflect growth of multiple product lines in the
segment, driven by double-digit growth in Droplet Digital PCR and Food Safety products as well as good
demand within Gene Expression and Western Blotting product lines. Sales during the third quarter of 2019
increased across all regions: the Americas, Europe and Asia.
• Clinical Diagnostics segment net sales for the third quarter were $341.8 million, an increase of 2.4 percent
compared to the same period in 2018. On a currency-neutral basis, net sales were up 4.3 percent compared to the
same quarter last year. Currency-neutral sales from the third quarter reflected growth in Quality Control, Blood
Typing, and Immunology product lines. On a geographic view, sales increased mainly in Asia and the Americas.
• Third-quarter 2019 operating income was $57.5 million versus 2018 third-quarter operating income of $36.3
million.
• Reported net income for the third quarter of 2019 was a net loss of $258.8 million, or ($8.68) per share on a
diluted basis. This loss was negatively impacted by a decline of $390.6 million in the market value of equity
securities that we hold, primarily related to our investment in Sartorius AG. Net income for the third quarter of
2018 was a net gain of $269.3 million, or $8.89 per share on a diluted basis, which included a gain of $318.0
million related to our investment holdings.
• The effective tax rate for the third quarter of 2019 was 22.8 percent compared to 23.1 percent during the same
quarter in 2018.
Executive Commentary
"We are pleased with our operating results for the third quarter, which show continued strength in many of
our key life science and diagnostic product lines across most of our major geographies," said Bio-Rad
President and Chief Executive Officer. "Our operating performance reflects continued improvement
compared to 2018, providing us with good momentum as we head into the rest of the year."
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Boston Scientific (USA) Announces Results For Third Quarter
2019
• Reported third quarter sales of $2.707 billion, representing an increase of 13.1 percent on
a reported basis, compared to the company's guidance range of 8 to 10 percent; 14.2 percent
on an operational basis; and 9.3 percent on an organic basis, compared to the company's
guidance range of 7.5 to 9 percent, all compared to the prior year period.
• Reported GAAP earnings of $0.09 per share compared to the company's guidance range of
$0.23 to $0.25 per share, due to acquisition-related charges in the quarter primarily
associated with the acquisition of BTG plc (BTG Acquisition or BTG).
• The company reported GAAP earnings of $126 million or $0.09 per share (EPS), compared
to GAAP earnings of $432 million or $0.31 per share a year ago, and achieved adjusted
earnings per share of $0.39 for the period, compared to $0.35 a year ago.
Achieved third quarter revenue growth in all segments compared to the prior year period
(excludes BTG Acquisition†):
• MedSurg: 13.2 percent reported, 14.1 percent operational and 10.5 percent organic
• Rhythm and Neuro: 5.4 percent reported, 6.5 percent operational and 3.9 percent organic
• Cardiovascular: 11.3 percent reported, 12.6 percent operational and 12.6 percent organic
Reported third quarter revenue growth in all regions, compared to the prior year period
(excludes BTG Acquisition†):
• U.S.: 10.6 percent reported and operational
• EMEA (Europe, Middle East and Africa): 6.3 percent reported and 10.8 percent operational
• APAC (Asia-Pacific): 13.8 percent reported and 14.2 percent operational
• Emerging Markets4: 16.1 percent reported and 19.3 percent operational
Executive Commentary
"Our third quarter results reflect accelerated growth fueled by several key product
launches, excellent regional performance and the broad strength of our core portfolio,
and we continue to invest in building a robust pipeline," said Chairman and chief
executive officer, Boston Scientific. "I am proud of our global teams across Boston
Scientific who continue to bring forward new clinical solutions that advance science and
help improve patient lives."
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Bristol-Myers Squibb (USA) Reports Third Quarter Financial
Results
• Bristol-Myers Squibb posted third quarter revenues of $6.0 billion, an increase of 6% compared to
the same period a year ago. Revenues increased 7% when adjusted for foreign exchange impact.
• U.S. revenues increased 7% to $3.5 billion in the quarter compared to the same period a year ago.
International revenues increased 3%. When adjusted for foreign exchange impact, international
revenues increased 7%.
• Gross margin as a percentage of revenue decreased from 71.0% to 69.9% in the quarter primarily
due to product mix.
• Marketing, selling and administrative expenses decreased 4% to $1.1 billion in the quarter.
• Research and development expenses increased 8% to $1.4 billion in the quarter.
• The effective tax benefit rate was 1.3% in the quarter, compared to an effective tax rate of 11.8% in
the same period a year ago. The decrease in the effective tax rate was due to jurisdictional tax rates
and other tax impacts attributed to pension settlement charges and the UPSA business divestiture gain
in 2019.
• The company reported net earnings attributable to Bristol-Myers Squibb of $1.4 billion, or $0.83 per
share, in the third quarter, compared to net earnings of $1.9 billion, or $1.16 per share, for the same
period a year ago.
• The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.9 billion,
or $1.17 per share, in the third quarter, compared to net earnings of $1.8 billion, or $1.09 per share,
for the same period a year ago. An overview of specified items is discussed under the “Use of
Non-GAAP Financial Information” section.
• Cash, cash equivalents and marketable securities were $33.5 billion as of September 30, 2019. The
net cash position was $8.5 billion as of September 30, 2019.
Executive Commentary
“In the third quarter, we delivered strong business performance and made important progress
with our pipeline, including the potential to bring our dual Immuno-Oncology combination to
patients with lung cancer, a disease where the unmet need remains high,” said Chairman and
chief executive officer, Bristol-Myers Squibb. “With strong momentum in our R&D and
commercial organizations, I am looking forward to the tremendous opportunity when
Bristol-Myers Squibb and Celgene come together as one, to deliver innovative medicines and
transform patients’ lives.”
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Cardinal Health (USA) Reports First Quarter Results for Fiscal
Year 2020
• First quarter GAAP operating loss was $5.3 billion and included a $5.6 billion accrual related
to opioid litigation. Non-GAAP operating earnings increased 6 percent to $577 million. GAAP
diluted loss per share was $16.65, while non-GAAP diluted earnings per share (EPS) decreased
2 percent to $1.27.
• First quarter revenue for the Pharmaceutical segment increased 6 percent to $33.4 billion due
to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.
• Pharmaceutical segment profit decreased 3 percent to $398 million in the first quarter, which
reflects the adverse impact of Pharmaceutical Distribution customer contract renewals, partially
offset by benefits from cost savings initiatives and the performance of Specialty Solutions.
• First quarter revenue for the Medical segment increased 3 percent to $3.9 billion due to organic
growth across the segment, led by products and distribution, and Cardinal Health at Home. This
was partially offset by the divestiture of the naviHealth business.
• Medical segment profit increased 26 percent to $170 million in the first quarter, which reflects
the benefits from cost savings initiatives, as well as growth in products and distribution, services,
and Cardinal Health at Home. This was partially offset by the divestiture of the naviHealth
business.
• Cardinal Health board of directors approved a quarterly dividend of $0.4811 per share. The
dividend will be payable on January 15, 2020 to shareholders of record at the close of business
on January 2, 2020.
• During the first quarters of fiscal 2020 and 2019, GAAP effective tax rates were 7.9 percent and
19.4 percent, respectively. Non-GAAP effective tax rates were 23.7 percent and 14.0 percent,
respectively.
Executive Commentary
"We are off to a solid start to fiscal year 2020, giving us confidence in our operating rigor
and path forward," said CEO of Cardinal Health. "Our disciplined cost management is
enabling strategic investment across the enterprise. We recognize that as our industry and the
healthcare sector continue to evolve, there is more work to be done. Our core capabilities,
deep industry knowledge and scale position us to adapt and deliver long-term shareholder
value."
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Centene (USA) and WellCare Announce Approval of Pending Transaction by
New York State Insurance and Healthcare Departments
Centene Corporation and WellCare Health Plans, Inc.
announced that the New York Department of Financial
Services and Department of Health have each approved
Centene's pending indirect acquisition of New York
domiciled WellCare insurance subsidiaries, bringing the
total number of states to approve the transaction to
25.The companies continue to expect that the transaction
will be completed by the first half of 2020.Completion
of the transaction remains subject to clearance under the
Hart-Scott-Rodino Act, receipt of the remaining required
state regulatory approvals and other customary closing
conditions.
Executive Commentary
"We are pleased that the New York State Department
of Financial Services and Department of Health have
joined 24 other states in issuing approvals," said
Centene's Chairman, President and Chief Executive
Officer. "These approvals bring us another step closer
toward completing the combination of Centene and
WellCare. We will continue to work with state
insurance regulators in the remaining states needed
for approval to demonstrate how we are creating a
leading healthcare enterprise that is committed to
helping people live healthier lives."
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Centene Corporation (USA) Reports 2019 Third Quarter Results
• September 30, 2019 managed care membership of 15.3 million, an increase
of 884,200 members, or 6%, over September 30, 2018.
• Total revenues for the third quarter of 2019 of $19.0 billion, representing
17% growth compared to the third quarter of 2018.
• Health benefits ratio (HBR) of 88.2% for the third quarter of 2019, compared
to 86.3% in the third quarter of 2018.
• Selling, general and administrative (SG&A) expense ratio of 8.9% for the
third quarter of 2019, compared to 12.6% for the third quarter of 2018.
• Adjusted SG&A expense ratio of 8.8% for the third quarter of 2019,
compared to 10.0% for the third quarter of 2018.
• Diluted EPS for the third quarter of 2019 of $0.23, compared to $0.05 for the
third quarter of 2018, an increase of 360%.
• Adjusted Diluted EPS for the third quarter of 2019 of $0.96, compared to
$0.89 for the third quarter of 2018, an increase of 8%.
• Operating cash flow of $(99) million for the third quarter of 2019 driven by
the payment of approximately $1.0 billion related to the 2018 risk adjustment
to CMS and minimum MLR programs, partially offset by net earnings. Cash
flow provided by operations for the nine months ended September 30, 2019
was $2.1 billion.
Executive Commentary
"We are pleased with our third quarter results which reflect growth in our
marketplace business, Medicaid business, and new programs,
demonstrating the benefits of our diversification strategy on our healthcare
enterprise. Looking ahead, we will continue to further enhance our
leadership position in government-sponsored healthcare," said Centene's
Chairman, President and Chief Executive Officer.
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Cigna’s (USA) Continued Momentum Drives Strong Third Quarter
2019 Results And Increased Revenue And Earnings Outlook
• Total revenues for third quarter 2019 were $38.6 billion. Adjusted
revenues1 were $35.8 billion and reflect strong contributions from each of
Cigna's ongoing businesses.
• Shareholders’ net income for third quarter 2019 was $1.35 billion, or
$3.57 per share, compared with $0.77 billion, or $3.14 per share, for third
quarter 2018.
• Cigna's adjusted income from operations2 for third quarter 2019 was
$1.72 billion, or $4.54 per share, compared with $0.95 billion, or $3.84 per
share, for third quarter 2018. This reflects strong earnings contributions led
by the Health Services and Integrated Medical segments.
• The total medical customer base6 at third quarter 2019 grew to 17.1
million, an organic increase of 110,000 customers year to date and 212,000
over third quarter 2018 driven by growth in the Select and Middle Market
segments, partially offset by a decline in National Accounts.
• The pharmacy customer base6 at third quarter 2019 grew to 75.7 million,
an organic increase of 2.4 million customers year to date, driven by strong
new commercial sales.
Executive Commentary
“Cigna's strong results and continued momentum reflect the
differentiated value we create for our customers and clients,” said
President and Chief Executive Officer. “Our combination with Express
Scripts enables us to leverage industry leading capabilities and more
rapidly innovate to enhance clinical and cost outcomes for those we
serve.”
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Community Health Systems (USA) Announces Definitive Agreements
to Sell Three Virginia Hospitals
Community Health Systems, Inc. announced that affiliates of the Company have signed a definitive agreement to sell
three Virginia hospitals – 300-bed Southside Regional Medical Center in Petersburg, 105-bed Southampton Memorial
Hospital in Franklin and 80-bed Southern Virginia Regional Medical Center in Emporia, and their associated assets to
subsidiaries of Bon Secours Mercy Health, Inc. The transaction is expected to close by the end of 2019, subject to
customary regulatory approvals and closing conditions.Community Health Systems, Inc. is one of the largest publicly
traded hospital companies in the United States and a leading operator of general acute care hospitals in communities
across the country. The Company, through its subsidiaries, owns, leases or operates 102 affiliated hospitals in 18 states
with an aggregate of approximately 17,000 licensed beds. The Company’s headquarters are located in Franklin,
Tennessee, a suburb south of Nashville. Shares in Community Health Systems, Inc. are traded on the New York Stock
Exchange under the symbol “CYH.”
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Community Health Systems, Inc. (USA) Announces Third Quarter
2019 Results
• Net operating revenues for the three months ended September 30, 2019, totaled $3.246 billion, a 5.9 percent decrease, compared with $3.451 billion for the same period
in 2018.
• Net loss attributable to Community Health Systems, Inc. common stockholders was $(17) million, or $(0.15) per share (diluted), for the three months ended September
30, 2019, compared with $(325) million, or $(2.88) per share (diluted), for the same period in 2018. Excluding the adjusting items as presented in the table in footnote
(e) on page 15, net loss attributable to Community Health Systems, Inc. common stockholders was $(0.29) per share (diluted), for the three months ended September 30,
2019, compared with $(1.64) per share (diluted) for the same period in 2018. Weighted-average shares outstanding (diluted) were 114 million for the three months ended
September 30, 2019, and 113 million for the three months ended September 30, 2018.
• Adjusted EBITDAfor the three months ended September 30, 2019, was $388 million compared with $372 million for the same period in 2018, representing a 4.3 percent
increase.
• The consolidated operating results for the three months ended September 30, 2019, reflect a 9.2 percent decrease in admissions, and an 8.4 percent decrease in adjusted
admissions, compared with the same period in 2018. On a same-store basis, admissions increased 2.4 percent and adjusted admissions increased 3.6 percent for the three
months ended September 30, 2019, compared with the same period in 2018. On a same-store basis, net operating revenues increased 4.1 percent for the three months
ended September 30, 2019, compared with the same period in 2018.
• Net operating revenues for the nine months ended September 30, 2019, totaled $9.925 billion, a 7.3 percent decrease, compared with $10.702 billion for the same period
in 2018.
• Net loss attributable to Community Health Systems, Inc. common stockholders was $(302) million, or $(2.66) per share (diluted), for the nine months ended September
30, 2019, compared with $(460) million, or $(4.08) per share (diluted), for the same period in 2018. Excluding the adjusting items as presented in the table in footnote
(e) on page 15, net loss attributable to Community Health Systems, Inc. common stockholders was $(1.29) per share (diluted), for the nine months ended September 30,
2019, compared with $(1.52) per share (diluted) for the same period in 2018. Weighted-average shares outstanding (diluted) were 114 million for the nine months ended
September 30, 2019, and 113 million for the nine months ended September 30, 2018.
• Adjusted EBITDA for the nine months ended September 30, 2019, was $1.181 billion compared with $1.223 billion for the same period in 2018, representing a 3.4
percent decrease.
• The consolidated operating results for the nine months ended September 30, 2019, reflect an 11.4 percent decrease in admissions, and an 11.2 percent decrease in
adjusted admissions, compared with the same period in 2018. On a same-store basis, admissions increased 1.7 percent and adjusted admissions increased 2.3 percent for
the nine months ended September 30, 2019, compared with the same period in 2018. On a same-store basis, net operating revenues increased 4.3 percent for the nine
months ended September 30, 2019, compared with the same period in 2018.
Executive Commentary
Commenting on the results, Chairman and chief executive officer of Community Health Systems, Inc., said, “We delivered a strong same-store performance
across key metrics during the third quarter. Continued execution of our transfer program, Accountable Care Organizations, capital investments, and strategic plans
have driven these improved results. We believe these investments, along with recent divestitures and ongoing operating efficiency initiatives, have positioned the
Company for continued improved performance. As we move forward, we expect a good finish to this year and believe we are well-positioned to deliver a strong
performance in 2020.”
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DSM (Netherlands) reports results first nine months 2019
• DSM reports good first nine months, with a solid performance in Q3
• Group sales +3%, Adjusted EBITDA up 11% (including 3% from IFRS 16)
• Nutrition: organic sales +4%, Adjusted EBITDAup 13% (including 3% from
IFRS 16)
• Materials: organic sales –7% (-5% volume), Adjusted EBITDA flat
(including 2% from IFRS 16)
• Total Net profit €640m, up versus first nine months 2018 of €821m when
correcting for the temporary vitamin effect of €290m EBITDA
• Adjusted Net Operating Free Cash Flow €550m, up 4% versus first nine
months 2018 which included the temporary vitamin effect of €290m EBITDA
Executive Commentary
CEO/Chairman DSM Managing Board commented: “I am pleased to
report again a good nine-month performance, together with a solid third
quarter.In the quarter, Nutrition delivered a good performance with 4%
organic growth and Adjusted EBITDA up 12%, despite some softness in
Human Nutrition. Materials experienced ongoing challenging conditions
in some of its end-markets, especially in China. Dyneema continued to
perform strongly. The earnings performance highlights the relative
resilience of our specialty Materials portfolio with a slight Adjusted
EBITDAdecline of 2%. We made good progress, with our large innovation
projects, like Veramaris, Clean Cow and Avansya.We are on track to
deliver 2019 in line with our targets, and therefore maintain our full year
outlook. DSM continues to be well positioned to deliver its ambitious
Strategy 2021, with its growth platforms together with increased customer
centricity and its large innovation projects, while at the same time
remaining focused on cost control and operational excellence.”
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Edwards Lifesciences (USA) Reports Third Quarter Results
• Sales for the quarter ended September 30, 2019 were $1.1 billion, up 21 percent over the prior year, or 19
percent on an underlying basis. Diluted earnings per share for the quarter were $1.30, while adjusted
earnings per share grew 32 percent, higher than expected, to $1.41.
• For the quarter, the company reported TAVR sales of $700 million, an increase of 26 percent over the third
quarter last year, or 27 percent on an underlying basis. Global average selling prices remained stable, and
the company estimates its global competitive position was consistent with the second quarter and prior
year.
• For the quarter, the company's adjusted gross profit margin was 75.9 percent, compared to 75.5 percent in
the same period last year. This improvement was driven primarily by the favorable impacts from foreign
exchange and product mix, partially offset by spending in support of the new European device regulations
and manufacturing variances.
• Selling, general and administrative expenses increased 14 percent to $306 million for the quarter, driven
by transcatheter structural heart field personnel related expenses, including expanding the TMTT field
organization in Europe.
• Research and development for the third quarter increased 21 percent to $196 million, or 18 percent of
sales. This increase was primarily the result of significant investments in the company's transcatheter
structural heart programs, including generating clinical evidence.
• During the quarter, the company recorded an additional $27 million charge, primarily inventory, related
to last quarter's strategic decisions regarding its transcatheter aortic valve portfolio.
• Adjusted free cash flow for the third quarter was $319 million, defined as cash flow from operating
activities of $437 million, less capital spending of $76 million, and excluding a $42 million tax benefit
related to the company's previously announced litigation settlement.
Executive Commentary
"We are very pleased to report strong third quarter results, which reflected a large increase in the
number of patients that were treated with transcatheter heart valve therapy," said Chairman and CEO.
"Our results were significantly higher than expected this quarter following the strong PARTNER 3
trial evidence that led to the recent FDA indication expansion of our SAPIEN 3 and SAPIEN 3 Ultra
systems. Additionally, at a recent clinical meeting it was exciting to observe new evidence that once
again demonstrated significant quality of life improvements for patients that received SAPIEN
valves."
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Lilly (USA) Reports Strong Third-Quarter 2019 Financial Results
• In the third quarter of 2019, worldwide revenue was $5.477 billion, an increase of 3 percent compared with the third quarter of 2018, and an increase of 4 percent when excluding the
impact of foreign exchange rates. The increase in revenue was driven by an 8 percent increase due to volume, partially offset by a 4 percent decrease due to lower realized prices.
• Revenue in the U.S. was essentially flat at $3.060 billion, as increased volume of 5 percent was offset by lower realized prices. Increased U.S. volume for key growth products including
Trulicity, Taltz, Emgality, Jardiance®, Verzenio®, and Basaglar®, was partially offset by decreased volume for Cialis® due to loss of patent exclusivity, as well as the impact from the
product withdrawal of Lartruvo®. Lower realized prices in the U.S. were primarily due to increased coverage gap funding requirements in Medicare Part D and higher contracted rebates
• Revenue outside the U.S. increased 8 percent, to $2.416 billion, driven by increased volume of 12 percent, which was primarily from key growth products, including Trulicity,
Olumiant®, Jardiance, Taltz, and Verzenio, partially offset by decreased volume for Strattera® due to loss of patent exclusivity and the impact of the product withdrawal of Lartruvo.
The increase in revenue due to volume was partially offset by the unfavorable impact of foreign exchange rates and lower realized prices.
• Gross margin increased 4 percent, to $4.302 billion, in the third quarter of 2019 compared with the third quarter of 2018. Gross margin as a percent of revenue was 78.5 percent, an
increase of 0.2 percentage points compared with the third quarter of 2018. The increase in gross margin percent was primarily due to the favorable effect of foreign exchange rates on
international inventories sold, lower intangibles amortization expense and greater manufacturing efficiencies, partially offset by unfavorable product mix primarily as a result of the loss
of patent exclusivity for Cialis, and the impact of lower realized prices on revenue.
• Operating expenses in the third quarter of 2019, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 2 percent to $2.793
billion compared with the third quarter of 2018. Research and development expenses increased 8 percent to $1.381 billion, or 25.2 percent of revenue, driven by higher development
expenses for late-stage assets. Marketing, selling, and administrative expenses decreased 3 percent, to $1.412 billion, as lower spending on late life-cycle products, lower litigation
charges, and ongoing cost containment measures were partially offset by increased expenses for recently launched products.
• In the third quarter of 2019, the company recognized acquired in-process research and development charges of $77.7 million, related to the previously announced business development
transactions with Centrexion Therapeutics Corporation and AC Immune SA. In the third quarter of 2018, the company recognized acquired in-process research and development charges
of $30.0 million related to a collaboration with Anima Biotech.
• Operating income in the third quarter of 2019 was $1.431 billion, compared to $1.343 billion in the third quarter of 2018. The increase in operating income was primarily driven by
higher gross margin and lower asset impairment, restructuring, and other special charges, partially offset by higher operating expenses and higher acquired in-process research and
development charges.
• Other expense was $24.9 million in the third quarter of 2019, compared with $1.9 million in the third quarter of 2018. The increase in other expense was primarily driven by higher
net interest expense, partially offset by higher net gains on investment securities.
• The effective tax rate was 10.8 percent in the third quarter of 2019, compared with 18.5 percent in the third quarter of 2018.
• In the third quarter of 2019, net income and earnings per share were $1.254 billion and $1.37, respectively, compared with net income of $1.150 billion and earnings per share of $1.12
in the third quarter of 2018.
Executive Commentary
"Lilly continued to deliver strong results in the third quarter, due in large part to the growth of our newer medicines and our ability to effectively manage costs while supporting
global launches in highly competitive classes and funding our next generation of new therapies," said Lilly's chairman and CEO. "Lilly's revenue growth is being driven by
volume, not price, as more and more patients are benefiting from our recently launched medicines. Our sustained investments in oncology, diabetes, immunology, and
neuroscience research continue to be productive, with several new medicines expected to be submitted, launch and then reach patients over the next few years."
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Fresenius (Germany) Helios acquires medical diagnostics
provider in Colombia
Quirónsalud, Spain’s largest private hospital group and part of Fresenius Helios, has acquired CediMed, a
leading medical diagnostics group in Colombia. CediMed operates seven centrally located centers in
Medellin, a major city of 2.5 million people. The company offers a comprehensive range of state-of-the-art
diagnostic imaging and laboratory services. The total investment is about €40 million. Following
Quirónsalud's entry into Colombia in 2019, this is another step in strengthening the company’s presence in
Latin America’s growing and consolidating healthcare services markets. Fresenius Helios expects the
transaction to close in the next few months, pending antitrust clearance.
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Gilead Sciences Announces Third Quarter 2019 Financial Results
• Total revenues were $5.6 billion for the third quarter of 2019 compared to $5.6 billion for the same period in 2018.
• Net loss for the third quarter of 2019 was $1.2 billion, or $0.92 per diluted share, compared to net income of $2.1 billion or $1.60 per diluted share for the same period in
2018.
• The net loss for the third quarter of 2019 includes up-front collaboration and licensing expenses of $3.92 billion, or $2.40 per share, related to Gilead’s global research and
development collaboration agreement with Galapagos NV (Galapagos).
• Non-GAAP net income was $2.2 billion or $1.75 per diluted share for the third quarter of 2019 compared to $2.4 billion or $1.84 per diluted share for the same period in
2018.
• HIV product sales were $4.2 billion for the third quarter of 2019 compared to $3.7 billion for the same period in 2018. The increase was primarily driven by higher sales
volume as a result of the continued uptake of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg).
• Chronic hepatitis C virus (HCV) product sales were $674 million for the third quarter of 2019 compared to $902 million for the same period in 2018. The decline was
primarily due to competitive dynamics.
• Yescarta® (axicabtageneciloleucel) generated $118 million in sales during the third quarter of 2019 compared to $75 million for the same period in 2018. The increase was
driven by a higher number of therapies provided to patients and the continued expansion in Europe.
• As of September 30, 2019, Gilead had $25.1 billion of cash, cash equivalents and marketable debt securities, compared to $31.5 billion as of December 31, 2018.
• During the third quarter of 2019, Gilead generated $2.6 billion in operating cash flow, paid $5.05 billion in connection with the global research and development
collaboration agreement and stock purchase agreement with Galapagos, repaid $1.5 billion of debt, paid cash dividends of $804 million and utilized $223 million on stock
repurchases. The $5.05 billion paid to Galapagos was classified as cash flows from investing activities and included a $1.1 billion equity investment.
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GSK (UK) delivers 3rd Quarter sales
• Reported Group sales £9.4 billion +16% AER, +11% CER (Pro-forma growth +6%
CER*); Pharmaceuticals £4.5 billion +7% AER, +3% CER; Vaccines £2.3 billion +20%
AER, +15% CER; Consumer Healthcare
• £2.5 billion +30% AER, +25% CER (Pro-forma growth +3% CER*)
• Total Group operating margin 22.9%; Adjusted Group operating margin 29.7%
reflecting increased spending on R&D and priority assets, and the impact of generic
Advair in the US, partly offset by Vaccines performance (Pharmaceuticals 24.1%;
Vaccines 50.3%; Consumer Healthcare 24.3%)
• Total EPS 31.4p +9% AER, -1% CER, Adjusted EPS 38.6p +9% AER, +1% CER
reflecting operating performance and lower effective tax rate offset by increased profit
allocation to non-controlling interests
• 9 months net cash flow from operations £4.6 billion. Free cash flow £2.5 billion
• 19p dividend declared for the quarter, continue to expect 80p for FY19
• Consumer Healthcare JV with Pfizer completed 31 July creating new world leader in
Consumer Healthcare
• 2019 Adjusted EPS guidance improved to expectation of around flat at CER from a
decline of -3% to -5%
Executive Commentary
Chief Executive Officer, GSK said: “GSK has made further good progress in Q3,
with sales growth across all three businesses, and we have today upgraded our
full-year EPS guidance. This quarter we have continued to strengthen our pipeline
and have advanced assets in Respiratory, HIV and, notably, Oncology, where we are
on track to file three innovative medicines by year end, following positive pivotal
trial data. We also achieved a significant milestone with the completion of our new
Consumer Healthcare Joint Venture with Pfizer, to create a new world leading
consumer healthcare business.”
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Grifols (Spain) Reports Nine Month 2019 Results
• Reported EUR 3,737.8 million in revenues for the first nine months of 2019, growing by 14.5% and 9.7% excluding exchange rate variations for the period (cc).
• Revenues rose sharply in the third quarter, increasing by 14.9% (11.8% cc). The main growth drivers were robust demand for the Bioscience Division’s main plasma proteins, which noted 13.1% (9.8% cc) growth, and the positive performance of the Diagnostic Division
(4.1% and 1.8% cc), Hospital Division (12.1% and 11.9% cc) and Bio Supplies Division (122.7% and 116.8% cc).
• The Bioscience Division continues to serve as the company’s primary growth engine. The division’s revenues grew by 13.4% (8.4% cc) over the first three quarters to EUR 2,945.2 million.
• Revenues from the Diagnostic Division reached EUR 534.3 million for the first nine months of 2019, increasing by 3.2% (-0.3% cc). The transfusion medicine business line, led by the growth of the blood typing business in the U.S and China, contributed to the division’s
revenue growth.
• Hospital Division revenues grew by 9.3% (8.8% cc) to EUR 93.7 million, driven by strong sales in all of its business lines. The Bio Supplies Division expanded by 142.0% (133.1% cc) to EUR 186.4 million over the first nine months of 2019.
• Grifols sustained the upward trend in its operating margins in the third quarter of 2019. As of September 30, its gross margin was 46.4% (47.8% underlying), driven by strong demand for the main plasma proteins, optimized manufacturing efficiencies and a positive
cost evolution of plasma. Reported EBITDA for the first nine months of 2019 increased by 13.5% to EUR 1,066.1 million, with a 28.5% margin. Underlying EBITDA2 was 29.0%.
• Grifols continued to focus on innovation in the first three quarters to promote its long-term sustainable growth. Net R+D+i investments reached EUR 244.6 million, increasing by 16.5% compared to the same period last year. This figure includes in-house, external and
investee-led projects.
• Grifols also moved ahead with its planned CAPEX investments, allocating EUR 188.5 million (an increase of 16.0%) in the first three quarters to bolster its manufacturing capacity. These investments align with the company’s overriding objective to anticipate and meet
the market’s evolving needs, which is among its strategic growth pillars.
• Grifols’ financial results totaled EUR 265.4 million. The cost of debt remained stable in the third quarter compared to previous quarters at EUR 88.5 million, although exchange rate variations wielded a negative impact of EUR 9.3 million.
• Net profit totaled EUR 423.4 million in the first nine months of the year, representing a 9.6% decrease compared to the same period last year. This decline is mainly due to the evolution of interest rates and changes in accounting standards for leases (IFRS 16), which
amounted to EUR 20.2 million from January to September 2019. In 2018, Grifols’ net results included a financial positive impact of EUR 32 million generated from the divestment in TiGenix.
• The effective tax rate remained at 20%.
• Excluding the impact of IFRS 163, Grifols’ net financial debt stood at EUR 5,803.6 million, including EUR 792.1 million in cash. The net financial debt over EBITDA fell to 4.35x (4.20x cc), a significant improvement compared to the 4.78x reported in the first quarter
of 2019.
• Effective financial management remains a key priority for Grifols in order to optimize and reduce its debt levels and maintain a strong cash position. Inventory levels increased as a result of the strategic decision to continue building up plasma volumes to meet the strong
demand for plasma therapies.
• The company maintains a solid operating cash generation to meet its planned growth initiatives. Cash generation reached EUR 339.2 million over the first nine months of the year.
• As of September 30, 2019, Grifols had EUR 792.1 million in cash positions and more than EUR 420 million in undrawn lines of credit, raising its liquidity position to over EUR 1,200 million.
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Lundbeck (Denmark) completes the acquisition of Alder BioPharmaceuticals – a
company committed to transforming migraine treatment and prevention
H. Lundbeck A/S announced that it has successfully completed the acquisition of
Alder BioPharmaceuticals, Inc. a migraine-focused company based in Bothell,
Washington, for an aggregate cash consideration of up to approximately USD
1.95 billion (DKK 13 billion) net of cash, on a fully diluted basis. The transaction,
which was announced on 16 September 2019, significantly accelerates and
strengthens the build of Lundbeck’s pipeline. Lundbeck acquired Alder for an
upfront payment of USD 18.00 per share, in cash, along with one non-tradeable
Contingent Value Right (CVR) of USD 2.00 per share, payable – subject to
certain terms and conditions - upon approval of eptinezumab by the European
Medicines Agency (EMA), representing a total potential consideration of USD
20.00 per share.Lundbeck expects to submit eptinezumab for approval to
regulatory authorities in the European Union during 2020, followed by
submissions for approval in other regions around the world, including China and
Japan. Alder has also been developing ALD1910, a mAb designed to inhibit
pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine
prevention. Eptinezumab, together with ALD1910, will help establish Lundbeck
as an emerging leader in migraine and other pain syndromes.
Executive Commentary
President and CEO of Lundbeck, commented “I am very excited to welcome
Alder to Lundbeck. The completion of our acquisition of Alder with the
exciting investigational drug, eptinezumab, will expand the breadth of our
portfolio into migraine and represents a major step in the execution of our
Expand and Invest to Grow strategy and Lundbeck can now take part in
helping the migraine community where so much unmet need remains.”
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H. Lundbeck (Denmark): Double-digit growth for all strategic
brands in 9M 2019 and FY 2019 Results
• Revenue reached DKK 12,615 million in the first nine months of 2019 representing a decline of 9%
(9% in local currencies) compared to the same period last year. The decline was expected and a result
of generic competition on Onfi® - excluding Onfi, revenue grew by 5%
• The strategic brands grew by 29% thereby reaching DKK 6,706 million or 53% of total revenue
• Core EBIT reached DKK 4,010 million corresponding to a core EBIT margin of 31.8%
• EBIT reached DKK 3,317 million in the period compared to DKK 4,453 million in 2018 and the
EBIT margin reached 26.3%
• Core EPS reached DKK 15.40 in the period compared to DKK 19.96 the year before and reported
EPS declined 25% to DKK 12.27
• The acquisition of Alder BioPharmaceuticals, which was announced on 16 September 2019, has
been completed. Thereby Lundbeck obtains Alder’s intravenous (IV) therapy for migraine
prevention, eptinezumab with a U.S. PDUFA action date of 21 February 2020 in a transaction valued
at up to USD 1.95 billion net of cash. Q3 2019 is impacted by DKK 55 million in transaction costs
• Lundbeck closed the acquisition of Abide Therapeutics, Inc. in May 2019 and has transitioned it into
a Lundbeck drug discovery hub named Lundbeck La Jolla Research Center
• The financial guidance for 2019 is raised. Lundbeck now expects revenue to reach DKK 16.7 - 16.9
billion and EBIT to reach DKK 3.4 – 3.7 billion for 2019 compared to previously DKK 16.3 - 16.7
billion and DKK 3.2 - 3.6 billion, respectively
Executive Commentary
Lundbeck’s President and CEO said:“2019 has been an exciting year so far. We have come a long
way in executing the Expand and Invest to Grow strategy with the acquisitions of Alder and
Abide. We have significantly strengthened the pipeline and at the same time continued the strong
double-digit growth in our strategic brands. Lundbeck is well set to begin our next growth
phase.”
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Henry Schein (USA) Reports Record Third Quarter 2019 Financial
Results
• Net sales from continuing operations for the quarter ended September 28, 2019, were $2.5 billion, an increase of 6.5%
compared with the third quarter of 2018. The 6.5% increase included 7.6% growth in local currencies and a 1.1%
decline related to foreign currency exchange. In local currencies, internally generated sales increased 3.9% and growth
from acquisitions was 3.7%. Excluding approximately $21.7 million of low-margin sales to Covetrus under the
transition services agreement entered into in connection with the Animal Health spin-off, internal sales growth in local
currencies was approximately 3.0%.
• Net income attributable to Henry Schein, Inc. from continuing operations for the third quarter of 2019 was $134.9
million, or $0.91 per diluted share, compared with prior-year net income from continuing operations of $90.8 million,
or $0.59 per diluted share. Third quarter 2019 results include a pre-tax reduction in estimated restructuring costs of $0.8
million, or $0.01 per diluted share, which had been recorded in earlier periods.
• Dental sales of $1.5 billion increased 2.1%, consisting of 3.6% growth in local currencies and a 1.5% decline related
to foreign currency exchange. In local currencies, internally generated sales increased 1.7% and growth from
acquisitions was 1.9%.
• Medical sales of $803.7 million increased 11.3%, consisting of 11.4% growth in local currencies and a 0.1% decline
related to foreign currency exchange. In local currencies, internally generated sales increased 5.3% and growth from
acquisitions was 6.1%, primarily driven by the contribution from North American Rescue.
• Technology and Value-Added Services sales from continuing operations of $137.3 million increased 15.1%,
consisting of 15.8% growth in local currencies and a 0.7% decline related to foreign currency exchange. In local
currencies, internally generated sales increased 4.9% and growth from acquisitions was 10.9%, primarily driven by the
contribution from Lighthouse 360.
Executive Commentary
“Our third quarter financial results are solid with increases in diluted EPS from continuing operations of 54.2% on
a GAAP basis and 15.4% on a non-GAAP basis. We continue to make progress in growing organically with a focus
on sales of higher-margin products while making strategic investments to supplement growth in the years ahead,”
said Chairman of the Board and Chief Executive Officer of Henry Schein.
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Illumina Reports (USA) Financial Results for Third Quarter of
Fiscal Year 2019
• Revenue of $907 million, a 6% increase compared to $853 million in the third quarter of 2018
• GAAP net income attributable to Illumina stockholders for the quarter of $234 million, or $1.58 per diluted share, compared to $199
million, or $1.33 per diluted share, for the third quarter of 2018
• Non-GAAP net income attributable to Illumina stockholders for the quarter of $286 million, or $1.93 per diluted share, compared to
$227 million, or $1.52 per diluted share, for the third quarter of 2018. Non-GAAP net income excludes an unrealized net loss of $43
million from mark-to-market adjustments on our strategic investments, primarily from our marketable equity securities (see the table
entitled “Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders” for a reconciliation of
these GAAP and non-GAAP financial measures)
• Cash flow from operations of $267 million compared to $292 million in the third quarter of 2018
• Free cash flow (cash flow from operations less capital expenditures) of $218 million for the quarter compared to $228 million in the
third quarter of 2018
• Gross margin in the third quarter of 2019 was 71.5% compared to 70.0% in the prior year period. Excluding amortization of acquired
intangible assets, non-GAAP gross margin was 72.5% for the third quarter of 2019 compared to 71.1% in the prior year period.
• Research and development (R&D) expenses for the third quarter of 2019 were $151 million compared to $159 million in the prior year
period. Excluding restructuring charges, non-GAAP R&D expenses as a percentage of revenue were 16.4% compared to 18.6% in the
prior year period.
• Selling, general and administrative (SG&A) expenses for the third quarter of 2019 were $189 million compared to $197 million in the
prior year period. Excluding acquisition-related expenses and restructuring charges, non-GAAP SG&A expenses as a percentage of
revenue were 20.0% compared to 23.2% in the prior year period.
• Depreciation and amortization expenses were $47 million and capital expenditures for free cash flow purposes were $49 million
during the third quarter of 2019. At the close of the quarter, the company held $3.2 billion in cash, cash equivalents and short-term
investments, compared to $3.5 billion as of December 30, 2018.
Executive Commentary
“This was a solid quarter for Illumina, with product revenue in-line with expectations, and a stronger than expected revenue
contribution associated with partner collaborations to develop distributable clinical IVDs for Illumina sequencers,” said President
and CEO. “Third quarter NovaSeq system shipments represented the second highest since launch, and included capacity
expansion to support the UK Biobank initiative to sequence 450,000 whole genomes over the next several years. Additionally,
continued NovaSeq adoption resulted in the highest consumables pull-through quarter for the platform this year.”
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IQVIA (USA) Reports Third-Quarter 2019 Results
• Revenue for the third quarter of $2,769 million increased 7.9 percent at constant
currency and 6.7 percent on a reported basis, compared to the third quarter of 2018.
• Technology & Analytics Solutions (TAS) revenue of $1,095 million grew 10.0
percent at constant currency and 8.0 percent reported. Research & Development
Solutions (R&DS) revenue of $1,466 million grew 6.8 percent at constant currency,
despite the impact from pass throughs of approximately 200 basis points, and 6.1
percent reported.
• Contract Sales & Medical Solutions (CSMS) revenue of $208 million grew 5.1
percent on both a constant currency and reported basis.
• Third-quarter 2019 Adjusted EBITDA was $593 million. GAAP net income was
$57 million, and GAAP diluted earnings per share was $0.29. Adjusted Net Income
was $318 million and Adjusted Diluted Earnings per Share was $1.60, up 12.7
percent compared to the third quarter of 2018.
• R&D Solutions quarterly services net book-to-bill ratio 1.31x; next twelve months
revenue from backlog increased to $5.1 billion, representing 10.6 percent
year-over-year growth, 13.3 percent excluding pass throughs
• Full-year revenue guidance reaffirmed at mid-point on a constant currency basis
• Mid-point of Adjusted EBITDA and Adjusted Diluted EPS guidance reaffirmed
Executive Commentary
“The team delivered another quarter of excellent financial and operational
results,” said Chairman and CEO of IQVIA. “We continue to see strong
momentum in our TAS segment, demonstrated by important OCE wins and a
further acceleration of organic revenue growth. In R&DS, we delivered another
strong quarter of bookings. In addition, our next twelve months revenue from
backlog increased to $5.1 billion in the quarter, which positions us well for
continued R&DS revenue acceleration. We are also pleased to see the CSMS
turnaround materialize, with very good mid-single-digit growth in the quarter.”
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LabCorp (USA) Expands Services in Northwest Indiana and Surrounding Region Through
Acquisition of Diagnostic Clinical Laboratory Assets From South Bend Medical Foundation
LabCorp®, a leading global life sciences company that is deeply integrated in guiding
patient care, has completed its acquisition of the diagnostic clinical laboratory testing
business of South Bend Medical Foundation (SBMF), considerably enhancing the scope
of local services that LabCorp offers to hospitals, physicians, and patients across Indiana,
Michigan, Ohio, and Illinois. In addition, LabCorp and SBMF will collaborate to provide
integrated pathology services to customers in the region, providing an optimal
combination of SBMF’s professional pathology services and LabCorp’s advanced
technical capabilities, in addition to more efficient access to the leading specialty
services of LabCorp’s Dianon Pathology and Integrated Oncology laboratories. LabCorp
will operate SBMF’s former clinical laboratory in South Bend, Indiana, and patients in
the area will be able to access LabCorp’s testing through an expanded network of patient
service centers, including six former SBMF locations and four LabCorp at Walgreens
locations that have recently opened in southwest Michigan. SBMF, a non-profit
healthcare provider serving patients for more than 100 years, will continue to provide
professional pathology and blood banking services to hospitals and physicians, and will
expand its pathology services through a new collaborative relationship with LabCorp.
Executive Commentary
“This year, LabCorp is celebrating five decades of providing innovative,
customer-focused clinical laboratory services as part of our mission to improve
health and improve lives,” said Senior vice president of LabCorp Diagnostics’ North
Central Division. “I am proud and excited that we will begin our next 50 years by
expanding our presence in South Bend and the surrounding markets and establishing
a collaboration with the highly regarded pathologists and staff at SBMF.”
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LabCorp (USA) Announces 2019 Third Quarter Results
• Revenue for the quarter was $2.93 billion, an increase of 3.4% over $2.83 billion in the third quarter of 2018. The increase in revenue was
primarily due to acquisitions of 2.8% and organic growth of 2.2% (which includes the negative impact from PAMA of 0.9%), partially offset by
the disposition of businesses of 1.3% and negative foreign currency translation of 0.3%.
• Operating income for the quarter was $339.9 million, or 11.6% of revenue, compared to $343.4 million, or 12.1%, in the third quarter of 2018.
The decrease in operating income and margin was primarily due to lower Medicare and Medicaid pricing as a result of PAMA and higher
personnel costs (primarily driven by merit increases and one additional payroll day that predominantly impacted LabCorp Diagnostics), partially
offset by strong demand and LaunchPad savings.
• The Company recorded restructuring charges, special items, and amortization, which together totaled $90.6 million in the quarter, compared to
$85.7 million during the same period in 2018. Adjusted operating income (excluding amortization, restructuring charges, and special items) for
the quarter was $430.5 million, or 14.7% of revenue, compared to $429.1 million, or 15.2%, in the third quarter of 2018. Excluding the negative
impact from PAMA, adjusted operating income grew $28.1 million over last year.
• Net earnings for the quarter were $220.7 million, compared to $318.8 million in the third quarter of 2018. Diluted EPS were $2.25 in the quarter,
a decrease of 27.4% compared to $3.10 in the same period in 2018. The decline in net earnings and diluted EPS in the quarter was due to a net
gain on the disposition of the Food Solutions business in the third quarter of 2018, which increased net earnings and diluted EPS by $125.3
million and $1.22 per share, respectively. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $2.90 in the
quarter, an increase of 5.8% over $2.74 in the third quarter of 2018.
• Operating cash flow for the quarter was $455.6 million, compared to $251.9 million in the third quarter of 2018. The increase in operating cash
flow was primarily due to higher cash earnings and favorable working capital. Capital expenditures totaled $92.6 million, compared to $97.9
million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $363.0 million, compared to $154.0 million in
the third quarter of 2018.
• At the end of the quarter, the Company’s cash balance and total debt were $361.1 million and $6.6 billion, respectively. During the quarter, the
Company invested $149.2 million in acquisitions and repurchased $100.0 million of stock, representing approximately 0.6 million shares. As of
September 30, 2019, the Company had $950.0 million of authorization remaining under its share repurchase program.
Executive Commentary
“LabCorp delivered another excellent quarter, with solid results driven by strong demand across both businesses,” said Chairman and CEO
of LabCorp. “The enterprise posted robust gains in revenue and adjusted earnings per share, and we generated $363 million in free cash
flow as we continued to weave the two businesses together into a powerful unified whole. We continued our disciplined capital allocation
program, repurchasing $100 million of shares and successfully executing several tuck-in acquisitions. Covance excelled across all
measures and, despite the market headwinds we are experiencing, Diagnostics turned in another impressive performance. We occupy a
unique, differentiated market position in life sciences, giving us great optimism about our opportunity to grow the business and create
shareholder value for the rest of 2019 and for many years to come.”
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McKesson (USA) Reports Fiscal 2020 Second-Quarter Results
• Loss per diluted share of $(3.99) included charges of approximately $1.4 billion, or $5.73 per diluted share.
• During the first half of the fiscal year, McKesson returned $1.6 billion of cash to shareholders via $1.4 billion of common stock repurchases and
$148 million of dividend payments.
• For the first half of the fiscal year, McKesson used cash from operations of $159 million, and invested $184 million internally, resulting in
negative free cash flow of $343 million.
U.S. Pharmaceutical and Specialty Solutions Segment
• Revenues were $46.0 billion, up 10%, driven primarily by branded pharmaceutical price increases and increased specialty pharmaceutical
volume from the company’s largest retail national account customer, partially offset by branded to generic conversions.
• Operating profit was $639 million and operating margin was 1.39%. Adjusted operating profit was $641 million, up 1%, due to continued
growth in the specialty businesses, partially offset by customer and product mix. Adjusted operating margin was 1.39%, down 14 basis points,
primarily resulting from the higher volume of specialty pharmaceuticals.
European Pharmaceutical Solutions Segment
• Revenues were $6.6 billion, down 1% on a reported basis and up 4% on an FX-adjusted basis, driven primarily by growth in the pharmaceutical
distribution business.
• Operating profit was $1 million and operating margin was 0.02%. Adjusted operating profit was $41 million, down 23%, and adjusted operating
margin was 0.62%. On an FX-adjusted basis, adjusted operating profit was $43 million, down 19%, and adjusted operating margin was 0.62%,
down 18 basis points, driven by the challenging retail pharmacy environment in the U.K.
Medical-Surgical Solutions Segment
• Revenues were $2.1 billion, up 6%, driven primarily by growth in the Primary Care business, largely due to the increase in volume of
pharmaceutical products.
• Operating profit was $129 million and operating margin was 6.27%. Adjusted operating profit was $166 million, up 20%, and adjusted
operating margin was 8.07%, up 99 basis points. The year-over-year growth primarily reflects growth in the Primary Care business and the
lapping of bad debt expense in the prior year.
Executive Commentary
“McKesson’s second-quarter results reflect continued momentum across the business as well as further progress against our cost savings
initiatives,” said Chief executive officer. “As we look forward to the second half of our fiscal year, we remain confident in the strength of
our broad set of solutions and capabilities, delivering execution against our strategic imperatives as we become a more focused and
efficient organization.”
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Merck (USA) Announces Third-Quarter 2019 Financial Results
• Third-Quarter 2019 Worldwide Sales Were $12.4 Billion, an Increase of
15%; Sales Increased 16% Excluding Impact from Foreign Exchange; Growth
Driven by Oncology and Human Health Vaccines
• KEYTRUDA Sales Grew 62% to $3.1 Billion; Excluding the Impact of
Foreign Exchange, Sales Grew 64%
• Human Health Vaccines Sales Grew 17% to $2.5 Billion; Excluding the
Impact of Foreign Exchange, Sales Grew 18%
• Third-Quarter 2019 GAAP EPS was $0.74, an Increase of 1%; Third-Quarter
Non-GAAP EPS was $1.51, an Increase of 27%
• Company Narrows and Raises 2019 Full-Year Revenue Range to be
Between $46.5 Billion and $47.0 Billion, Including a Negative Impact from
Foreign Exchange of Approximately 2%
• Company Narrows and Reduces 2019 Full-Year GAAP EPS Range to be
Between $3.75 and $3.80; Narrows and Raises 2019 Full-Year Non-GAAP
EPS Range to be Between $5.12 and $5.17, Including a Negative Impact from
Foreign Exchange of Approximately 1%
Executive Commentary
“We achieved another quarter of strong revenue and earnings growth as we
continue to realize the benefits of our sustained investment in research and
development and our focus on commercial execution,” said Chairman and
chief executive officer, Merck. “We are confident that the investments we
are making now will allow us to convert cutting-edge science into
medicines and vaccines of great benefit to patients and value to
shareholders.”
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European Commission Approves Bavencio® (Avelumab) Plus Axitinib Combination
For First-Line Treatment Of Patients With Advanced Renal Cell Carcinoma
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. announced that the
European Commission (EC) has approved BAVENCIO® in combination with axitinib for the first-line treatment of adult patients with advanced renal cell
carcinoma (RCC). The approval was based on positive interim results from the Phase III JAVELIN Renal 101 study, which demonstrated that BAVENCIO in
combination with axitinib significantly lowered risk of disease progression or death by 31% (HR: 0.69 [95% CI: 0.574–0.825; p<0.0001]) and nearly doubled
objective response rate (ORR; 52.5% [95% CI: 47.7-57.2] vs. 27.3% [95% CI: 23.2-31.6]) compared with sunitinib in patients with advanced RCC regardless of
PD-L1 status. The study included patients across International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups.
Improvement in progression-free survival (PFS) was observed across pre-specified subgroups in patients receiving the treatment combination.1 Merck KGaA,
Darmstadt, Germany, and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.In 2018, an estimated 136,500 new cases of
kidney cancer were diagnosed in Europe, and approximately 54,700 people died from the disease.2 Many patients living with advanced RCC do not go on to
receive additional treatment after first-line therapy,3,4for reasons that may include poor performance status or adverse events from their initial treatment.3,5,6
The five-year survival rate for patients with advanced RCC is approximately 12%.
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Mylan And Pfizer (USA) Announce Viatris As The New Company Name In
The Planned Mylan-Upjohn Combination
HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. and Pfizer Inc.
announced that the name of the new company to be formed by the planned
combination of Mylan and Upjohn, a division of Pfizer, will be Viatris.
Deriving its name from Latin, Viatris embodies the new company’s goal of
providing a path—“VIA”—to three—“TRIS”—core goals: expanding access
to medicines, leading by innovating to meet patient needs, and being a trusted
partner for the healthcare community worldwide.Formed through a
combination of two highly complementary businesses, Viatris will unite
Upjohn’s strong leadership position in China and emerging markets with
Mylan’s significant presence in the U.S. and Europe, allowing the new
company to have a meaningfully expanded geographic reach for Viatris’ broad
product portfolio and future pipeline.It is expected that in the coming months,
shareholders of Mylan will vote on the proposed combination of Mylan and
Upjohn. More information regarding Viatris, including the company’s full
executive management team, board of directors, stock symbol, and logo will
be available at a later date.
Executive Commentary
“We wanted a name that would differentiate our new company and clearly
explain how we will be a champion for global health,” said Executive
Chairman of the new company, as previously announced. “We are creating
a company unlike any other – a company focused on building a more
hopeful and sustainable healthcare journey, empowering patients to live
healthier at every stage of life.”
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