On October 31, 2019 Amgen, one of the world’s leading biotechnology companies, reported that launches its first biosimilar for cancer treatment in the Brazilian market (Press release, Amgen, OCT 31, 2019, View Source [SID1234550154]). KANJINTI 1,2 (trastuzumab) has been approved by ANVISA (National Health Surveillance Agency) after passing tests that have proven its biosimilarity to Herceptin 3 .

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Targeted therapy is indicated for patients with the HE2-positive mutation who are undergoing treatment for early, metastatic breast cancer and advanced gastric cancer. "The arrival of KANJINTI in the Brazilian market is a milestone for Amgen, which aims to make affordable high cost biological therapies for patients with serious diseases, complementing our portfolio of cancer therapies and expanding treatment options in the country," says the director. Amgen’s doctor in Brazil, Tatiana Castello Branco .

KANJINTI is the only biosimilar in the Brazilian market that has undergone a phase III clinical study in which the transition from the reference drug to the biosimilar with the maintenance of clinical results. The data show that the new drug has no relevant clinical differences from the reference drug, demonstrating its safety and corresponding immunogenicity in patients already using the originator molecule.

Biosimilars and Metastatic Breast Cancer

Breast cancer is the most common cancer among Brazilian women: 59,700 new breast cancer cases are estimated for each year in 2018-2019, with an estimated risk of 56.33 cases per 100,000 women 4 . The TCU (Federal Audit Court) operational audit identified that the diagnosis of cancer in Brazil is made late. The arrival of biosimilars represents a real opportunity for Brazilian patients to access these technologies, especially in these advanced cases.

"Targeted therapy acts on tumor mutation and increases the chances of a positive response to treatment, offering real benefit to patients and broadening therapeutic options, although there are barriers related to the high cost of these drugs. The arrival of biosimilars in this scenario represents a great achievement for doctors and patients, as they offer the same efficacy and safety ratios with the best cost-benefit ratio, "says Ricardo Caponero , clinical oncologist at Hospital Alemão Oswaldo Cruz .

On October 31, 2019 Amgen (NASDAQ:AMGN) reported that it has entered into a strategic collaboration with BeiGene that will significantly accelerate Amgen’s plans to expand its oncology presence in China, the world’s second-largest pharmaceutical market (Press release, Amgen, OCT 31, 2019, View Source [SID1234550153]). BeiGene is a research-based, oncology-focused biotechnology company with an established and highly experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization.

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"This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our presence in the world’s most populous country," said Robert A. Bradway, Amgen’s chairman and chief executive officer. "Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. With its extensive commercial and clinical capabilities within China and a commitment to global quality standards, BeiGene is the ideal strategic collaborator as we seek to make a meaningful difference in the lives of millions of cancer patients in China and around the world."

As part of the collaboration:

Amgen will acquire a 20.5% stake in BeiGene for approximately $2.7 billion in cash. This represents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019. Amgen will nominate one person to serve on BeiGene’s Board of Directors.
Under the agreement, BeiGene will commercialize XGEVA (denosumab), KYPROLIS (carfilzomib) and BLINCYTO (blinatumomab) in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA was launched in China in September of this year; KYPROLIS and BLINCYTO are both in Phase 3 trials in China.
Amgen and BeiGene will collaborate to advance 20 medicines from Amgen’s innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on the sales of these products outside of China, with the exception of AMG 510, Amgen’s first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors. Amgen anticipates utilizing data from clinical trials conducted in China to advance the development of its oncology portfolio globally.
Of the 20 oncology medicines in development, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen. Amgen and BeiGene will share profits in China equally on these products until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.
Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha (evolocumab), an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.
XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in Amgen’s oncology pipeline, will be manufactured at Amgen’s existing facilities.
Since 2011, Amgen has expanded its geographic presence from approximately 50 to 100 countries, enabling the company to play a growing role in serving the rapidly increasing demand for better healthcare around the world. The pharmaceutical market in China is expected to grow briskly as access to new medicines continues to improve. With approximately four million people diagnosed with cancer annually and 2.3 million deaths from the disease each year, the need for new oncology treatments in China is particularly acute and the oncology market is one of the fastest-growing segments of the overall pharmaceutical market there.

Amgen will purchase its equity stake in BeiGene with available cash and expects to retain its investment grade credit rating.

"Amgen’s capital allocation priorities remain unchanged," said David W. Meline, executive vice president and chief financial officer at Amgen. "We will continue to grow our business through internal investment and business development, while providing attractive returns to our shareholders through a growing dividend and continued share repurchases."

The transaction is expected to close in early 2020 subject to BeiGene shareholder approval, the expiration or termination of waiting periods under all applicable antitrust laws, and satisfaction of other customary closing conditions.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Latham & Watkins LLP is serving as legal advisor to Amgen.

Webcast Details
Amgen will host a webcast call today at 2 p.m. PT. where members of Amgen’s executive management team will discuss the Company’s strategic collaboration with BeiGene.  

Live audio webcast of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.  

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.   

For more information about Amgen’s products, including important safety information, please visit www.xgeva.com, www.kyprolis.com, www.blincyto.com, www.repatha.com, and www.prolia.com.

On October 31, 2019 Bruker Corporation (Nasdaq: BRKR) reported financial results for its third quarter and for the nine months ended September 30, 2019 (Press release, Bruker, OCT 31, 2019, View Source [SID1234550152]).

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Third Quarter 2019 Financial Results

Bruker’s revenues for the third quarter of 2019 were $521.1 million, an increase of 11.7% compared to the third quarter of 2018. In the third quarter of 2019, Bruker’s year-over-year organic revenue growth was 7.6%. Growth from acquisitions was 6.4%, while foreign currency translation had a negative effect of 2.3%.

Third quarter 2019 Bruker Scientific Instruments (BSI) segment revenues of $471.8 million increased 13.1% year-over-year, including organic growth of 8.6%. Third quarter 2019 Bruker Energy & Supercon Technologies (BEST) segment revenues of $52.5 million increased 3.1% year-over-year, including an organic revenue decline of 0.8%, net of intercompany eliminations.

Third quarter 2019 GAAP operating income was $87.8 million, compared to $69.1 million in the third quarter of 2018, representing GAAP operating margins of 16.8% and 14.8%, respectively. Non-GAAP operating income was $95.5 million, compared to $83.3 million in the third quarter of 2018. Bruker’s third quarter 2019 non-GAAP operating margin of 18.3% increased 40 basis points from 17.9% in the third quarter of 2018.

Third quarter 2019 GAAP diluted earnings per share (EPS) were $0.39, compared to $0.28 in the third quarter of 2018. Non-GAAP EPS were $0.43, a 16.2% increase compared to $0.37 in the third quarter of 2018.

First Nine Months of 2019 Financial Results

For the first nine months of 2019, Bruker’s revenues were $1,472.7 million, an increase of 9.7% from $1,342.0 million in the first nine months of 2018. In the first nine months of 2019, Bruker’s organic revenue growth was 6.0% year-over-year. Growth from acquisitions was 7.0%, while foreign currency translation had a negative effect of 3.3%.

In the first nine months of 2019, BSI segment revenues of $1,331.0 million increased 10.3% year-over-year, including organic growth of 5.8%. First nine months 2019 BEST segment revenues of $152.2 million increased 9.3% year-over-year, including organic growth of 7.0%, net of intercompany eliminations.

In the first nine months of 2019, GAAP operating income was $183.2 million, compared to $156.0 million in the first nine months of 2018, representing GAAP operating margins of 12.4% and 11.6%, respectively. Non-GAAP operating income was $231.5 million, compared to $195.1 million in the first nine months of 2018. Bruker’s non-GAAP operating margin in the first nine months of 2019 was 15.7%, an increase of 120 basis points, compared to 14.5% in the first nine months of 2018.

In the first nine months of 2019, GAAP EPS were $0.82, compared to $0.65 in the first nine months of 2018. Non-GAAP EPS were $1.04, an increase of 20.9% over $0.86 in the first nine months of 2018.

A reconciliation of non-GAAP to GAAP financial measures is provided in the tables accompanying this press release.

Frank H. Laukien, President and CEO of Bruker, commented: "We are very pleased with our year-to-date progress, with 6% organic and 13% constant currency revenue growth, highlighted by our strong performance in life science mass spectrometry solutions and in microbiology. We are on track to deliver solid margin and EPS improvements in 2019, and we are increasing our non-GAAP EPS outlook for the full year."

Fiscal Year (FY) 2019 Financial Outlook

For FY 2019, Bruker continues to expect year-over-year revenue growth of 7.0% to 8.0%, which now includes the following estimates:

organic revenue growth of 4.5% to 5.5%;
growth from acquisitions of approximately 5.5%;
constant currency revenue growth of 10.0% to 11.0%; and
an increased foreign currency revenue headwind of approximately 3%.
Bruker continues to expect non-GAAP operating margin expansion in FY 2019 of 90 to 120 basis points over its FY 2018 non-GAAP operating margin of 16.8%. This now includes approximately 50 basis points of foreign currency tailwind. Bruker is raising its FY 2019 non-GAAP EPS outlook to a range between $1.59 and $1.62, representing a 13.5% to 15.5% increase compared to FY 2018.

For our outlook for FY 2019 non-GAAP operating margin and non-GAAP EPS, we are not able to provide without unreasonable effort the most directly comparable GAAP financial measures, or reconciliations to such GAAP financial measures on a forward-looking basis. Please see "Use of Non-GAAP Financial Measures" below for a description of items excluded from our expected non-GAAP operating margin and non-GAAP EPS.

Quarterly Earnings Call

Bruker will host a conference call and webcast to discuss its financial results, business outlook, and related corporate and financial matters today, October 31, at 4:30 p.m. Eastern Daylight Time. To listen to the webcast, investors can go to View Source and click on the "Q3 2019 Earnings Webcast" hyperlink. A slide presentation that will be referenced during the webcast will be posted to our Investor Relations website shortly before the webcast begins. Investors can also listen to the earnings webcast via telephone by dialing 1-888-437-2685 (US toll free) or +1-412-317-6702 (international) and referencing "Bruker’s Third Quarter 2019 Earnings Conference Call". A telephone replay of the conference call will be available by dialing 1-877-344-7529 (US toll free) or +1-412-317-0088 (international) and entering conference number: 10136323. The replay will be available beginning one hour after the end of the conference through December 1, 2019.

On October 31, 2019 Centene Corporation (NYSE: CNC) reported it will present at two healthcare conferences in November (Press release, CENTENE, OCT 31, 2019, View Source [SID1234550151]).

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At the Credit Suisse 28th Annual Healthcare Conference, to be held Nov. 11-13, 2019, at The Phoenician in Scottsdale, Ariz., Centene will present on Tuesday, November 12th, at 3:35 p.m. Mountain Standard Time (MST). A simultaneous live audio webcast is available at: View Source;tp_key=2d92dbb2f6&tp_special=8.

On Thursday, November 14th at 11:15 a.m. Central Standard Time (CST), Centene will present at the Stephens Nashville Investment Conference, to be held Nov. 13-15, 2019 at the Omni Nashville Hotel. A simultaneous live audio webcast is available at: View Source

Webcast replays of these presentations will be available afterwards via the Company’s website at www.centene.com under the Investors section.

On October 31, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare workforce solutions and staffing services, reported its third quarter 2019 financial results (Press release, AMN Healthcare Services, OCT 31, 2019, View Source [SID1234550150]). Financial highlights are as follows:

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Dollars in millions, except per share amounts.

* See "Non-GAAP Measures" below for a discussion of our use of non-GAAP items and the table entitled "Supplemental Financial and Operating Data" for a reconciliation of non-GAAP items.

Highlights

Third quarter financial results above high end of Company guidance
Strong demand continues with Nurse and Allied orders at a three-year high, while a tight labor market limits near-term volume growth
Advanced Medical, our recently acquired allied and nursing staffing business, is performing well with double-digit year-over-year revenue growth
Generated $72 million of free cash flow in Q3, driven in part by a reduction in DSO
On October 1, closed on new 8-year, $300 million unsecured debt financing to recharge the Company’s capacity for acquisitions and stock repurchases
"A solid demand environment and sound execution by the AMN team enabled us to beat expectations for revenue and earnings in the third quarter. As healthcare organizations increasingly seek total talent partners, we have been fortunate to expand and add progressive new clients. This gives us the opportunity to help clients optimize their workforce while also providing our candidates with even more attractive career opportunities," said Susan R. Salka, Chief Executive Officer of AMN Healthcare.

"The need for healthcare talent and workforce solutions by our clients has accelerated as labor market conditions remain very constrained. To ensure we have access to the best talent possible for our clients, we are continuing to utilize innovative recruitment strategies, and we have the ability to further leverage our expanded recruitment team from the recent Advanced acquisition," Ms. Salka added.

Third Quarter 2019 Results

Consolidated revenue for the quarter was $568 million, an 8% increase over prior year and 6% higher than prior quarter. On an organic basis, consolidated revenue was up 1% over prior year. Revenue for the Nurse and Allied Solutions segment was $363 million, up 18% year over year (6% organic) and 9% sequentially. Travel Nurse division revenue grew 10% year over year with 4% organic growth. Allied division revenue increased 46% year over year, 11% organic.

The Locum Tenens Solutions segment reported revenue of $84 million, down by 17% year over year but up 3% sequentially. Other Workforce Solutions segment revenue was $121 million for an increase of 1% year over year, driven by growth in our interim leadership and VMS businesses.

Gross margin was 33.5%, higher by 30 basis points year over year and flat sequentially. The year-over-year variance was driven by improved gross margins in the Nurse and Allied and Other Workforce Solutions segments.

SG&A expenses were $133 million, or 23.5% of revenue, compared with $121 million, or 23.0% of revenue, in the same quarter last year. SG&A was $122 million, or 22.7% of revenue, in the previous quarter. The year-over-year increase in SG&A costs came mainly from the recent acquisitions, a higher earn-out provision and higher employee-related expenses, partly offset by lower legal reserves.

Income from operations was $40 million, or 7.0% of revenue, compared with $43 million, or 8.1% of revenue, in the same quarter last year. Adjusted EBITDA was $69 million, a year-over-year increase of 3%. Adjusted EBITDA margin was 12.2%, representing a decrease of 60 basis points year over year.

Net income was $24 million, or $0.49 per diluted share, compared with $28 million, or $0.58 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.81.

At September 30, 2019, cash and cash equivalents totaled $41 million. Cash flow from operations was $81 million for the quarter, and capital expenditures were $9 million. The Company ended the quarter with total debt outstanding of $620 million, with a leverage ratio as calculated in accordance with the Company’s credit agreement of 2.2 to 1.

October Debt Refinancing

In October, AMN issued $300 million of 4.625% senior notes due in 2027 and used the proceeds to repay the Company’s revolving debt and term loan, which totaled $295 million. After these actions, the Company had total debt of $625 million and unused borrowing capacity of $383 million on its senior credit facility.

*Note: Guidance percentage metrics are approximate. For a reconciliation of adjusted EBITDA margin to operating margin, see the table entitled "Reconciliation of Guidance Adjusted EBITDA Margin to Guidance Operating Margin" below.

Revenue in the fourth quarter of 2019 is expected to be approximately 8-9% higher year over year. This guidance does not assume any material labor disruption revenue in the quarter.

Conference Call on October 31, 2019

AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, will host a conference call to discuss its third quarter 2019 financial results and outlook on Thursday, October 31, 2019, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 288-8960 in the U.S. or (612) 234-9960 internationally. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 7:30 p.m. Eastern Time on October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019, by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.