On April 26, 2017 Amgen (NASDAQ:AMGN) reported financial results for the first quarter of 2017 (Press release, Amgen, APR 26, 2017, View Source [SID1234518694]). Schedule your 30 min Free 1stOncology Demo! Key results include:
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Total revenues decreased 1 percent versus the first quarter of 2016 to $5.5 billion.
GAAP earnings per share (EPS) increased 12 percent to $2.79 driven by higher operating margins.
GAAP operating income increased 8 percent to $2.6 billion and GAAP operating margin increased 4 percentage points to 49.8 percent.
Non-GAAP EPS increased 9 percent to $3.15 driven by higher operating margins.
Non-GAAP operating income increased 5 percent to $3.0 billion and non-GAAP operating margin increased 3 percentage points to 57.6 percent.
2017 EPS guidance increased to $10.64-$11.32 on a GAAP basis and $12.00-$12.60 on a non-GAAP basis; total revenues guidance unchanged at $22.3-$23.1 billion.
The Company generated $2.2 billion of free cash flow in the first quarter versus $1.8 billion in the first quarter of 2016.
"We are well positioned for the long term with our newer products demonstrating volume growth around the world and our tight operational expense management of the Company," said Robert A. Bradway, chairman and chief executive officer. "With robust Repatha (evolocumab) outcomes data, we are working with payers to improve access to this important therapy for patients at risk for heart attacks and strokes."
$Millions, except EPS and percentages
Q1’17
Q1’16
YOY Δ
Total Revenues
$ 5,464
$ 5,527
(1%)
GAAP Operating Income
$ 2,591
$ 2,402
8%
GAAP Net Income
$ 2,071
$ 1,900
9%
GAAP EPS
$ 2.79
$ 2.50
12%
Non-GAAP Operating Income
$ 2,995
$ 2,859
5%
Non-GAAP Net Income
$ 2,333
$ 2,203
6%
Non-GAAP EPS
$ 3.15
$ 2.90
9%
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.
Product Sales Performance
Total product sales decreased 1 percent for the first quarter of 2017 versus the first quarter of 2016.
Neulasta (pegfilgrastim) sales increased 2 percent as favorable changes in accounting estimates and net selling price were offset partially by lower unit demand.
Enbrel (etanercept) sales decreased 15 percent due to the impact of competition as well as lower rheumatology and dermatology segment growth compared to prior quarters.
Aranesp (darbepoetin alfa) sales decreased 4 percent as higher unit demand was more than offset by unfavorable changes in foreign exchange rates, inventory and net selling price.
Prolia (denosumab) sales increased 21 percent driven by higher unit demand.
Sensipar/Mimpara (cinacalcet) sales increased 15 percent driven primarily by net selling price.
XGEVA (denosumab) sales increased 6 percent driven by higher unit demand.
EPOGEN (epoetin alfa) sales decreased 10 percent driven by net selling price.
KYPROLIS (carfilzomib) sales increased 23 percent driven by higher unit demand.
Nplate (romiplostim) sales increased 9 percent driven by higher unit demand.
NEUPOGEN (filgrastim) sales decreased 31 percent driven primarily by the impact of competition.
Vectibix (panitumumab) sales increased 2 percent driven by higher unit demand, offset partially by unfavorable changes in foreign exchange rates.
Repatha sales increased driven by higher unit demand.
BLINCYTO (blinatumomab) sales increased 26 percent driven by higher unit demand.
Product Sales Detail by Product and Geographic Region
$Millions, except percentages
Q1’17
Q1’16
YOY Δ
US
ROW
TOTAL
TOTAL
TOTAL
Neulasta
$1,048
$162
$1,210
$1,183
2%
Enbrel
1,118
63
1,181
1,385
(15%)
Aranesp
278
233
511
532
(4%)
Prolia
279
146
425
352
21%
Sensipar / Mimpara
337
84
421
367
15%
XGEVA
298
104
402
378
6%
EPOGEN
270
0
270
300
(10%)
KYPROLIS
137
53
190
154
23%
Nplate
97
57
154
141
9%
NEUPOGEN
101
47
148
213
(31%)
Vectibix
61
86
147
144
2%
Repatha
33
16
49
16
*
BLINCYTO
23
11
34
27
26%
Other**
15
42
57
47
21%
Total product sales
$4,095
$1,104
$5,199
$5,239
(1%)
* Change in excess of 100%
** Other includes Bergamo, MN Pharma, IMLYGICand Corlanor
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses decreased 8 percent, with all expense categories reflecting savings from our transformation and process improvement efforts. Cost of Sales margin improved by 0.2 percentage points driven primarily by manufacturing efficiencies, offset partially by product mix. Research & Development (R&D) expenses decreased 12 percent driven by a payment in the first quarter of 2016 related to a third-party collaboration agreement, as well as lower spending required to support certain later-stage clinical programs. Selling, General & Administrative (SG&A) expenses decreased 12 percent due to the expiration of ENBREL residual royalty payments and an acquisition charge in the first quarter of 2016, offset partially by investments in product launches.
Operating Margin improved by 4 percentage points to 49.8 percent.
Tax Rate decreased 0.1 percentage points as changes in the geographic mix of earnings were offset partially by lower tax benefits from share-based compensation payments.
On a non-GAAP basis:
Total Operating Expenses decreased 7 percent, with all expense categories reflecting savings from our transformation and process improvement efforts. Cost of Sales margin improved by 0.4 percentage points driven primarily by manufacturing efficiencies, offset partially by product mix. R&D expenses decreased 13 percent driven by a payment in the first quarter of 2016 related to a third-party collaboration agreement, as well as lower spending required to support certain later-stage clinical programs. SG&A expenses decreased 6 percent due to the expiration of ENBREL residual royalty payments, offset partially by investments in product launches.
Operating Margin improved by 3 percentage points to 57.6 percent.
Tax Rate decreased 0.4 percentage points as changes in the geographic mix of earnings were offset partially by lower tax benefits from share-based compensation payments.
$Millions, except percentages
GAAP
Non-GAAP
Q1’17
Q1’16
YOY Δ
Q1’17
Q1’16
YOY Δ
Cost of Sales
$996
$1,018
(2%)
$682
$707
(4%)
% of product sales
19.2%
19.4%
(0.2)pts
13.1%
13.5%
(0.4) pts
Research & Development
$769
$872
(12%)
$748
$858
(13%)
% of product sales
14.8%
16.6%
(1.8) pts
14.4%
16.4%
(2) pts
Selling, General & Administrative
$1,064
$1,203
(12%)
$1,039
$1,103
(6%)
% of product sales
20.5%
23.0%
(2.5) pts
20.0%
21.1%
(1.1) pts
Other
$44
$32
38%
$0
$0
NM
TOTAL Operating Expenses
$2,873
$3,125
(8%)
$2,469
$2,668
(7%)
Operating Margin
operating income as a % of product sales
49.8%
45.8%
4 pts
57.6%
54.6%
3 pts
Tax Rate
15.8%
15.9%
(0.1) pts
18.5%
18.9%
(0.4) pts
NM: Not Meaningful
pts: percentage points
Cash Flow and Balance Sheet
The Company generated $2.2 billion of free cash flow in the first quarter of 2017 versus $1.8 billion in the first quarter of 2016 driven by the timing of tax payments and higher net income.
The Company’s second quarter 2017 dividend of $1.15 per share declared on March 7, 2017, will be paid on June 8, 2017, to all stockholders of record as of May 17, 2017.
During the first quarter, the Company repurchased 3.4 million shares of common stock at a total cost of $555 million. At the end of the first quarter, the Company had $3.5 billion remaining under its stock repurchase authorization.
$Billions, except shares
Q1’17
Q1’16
YOY Δ
Operating Cash Flow
$2.4
$1.9
$0.5
Capital Expenditures
0.2
0.2
0.0
Free Cash Flow
2.2
1.8
0.5
Dividends Paid
0.8
0.8
0.1
Share Repurchase
0.6
0.7
(0.1)
Avg. Diluted Shares (millions)
741
760
(19)
Cash and Investments
38.4
34.7
3.7
Debt Outstanding
34.1
34.3
(0.2)
Stockholders’ Equity
30.6
28.7
2.0
Note: Numbers may not add due to rounding
2017 Guidance
For the full year 2017, the Company now expects:
Total revenues in the range of $22.3 billion to $23.1 billion, unchanged from previous guidance.
On a GAAP basis, EPS in the range of $10.64 to $11.32 and a tax rate in the range of 16 percent to 18 percent.
Previously, the Company expected GAAP EPS in the range of $10.45 to $11.31. Tax rate guidance is unchanged.
On a non-GAAP basis, EPS in the range of $12.00 to $12.60 and a tax rate in the range of 18.5 percent to 19.5 percent.
Previously, the Company expected non-GAAP EPS in the range of $11.80 to $12.60. Tax rate guidance is unchanged.
Capital expenditures to be approximately $700 million.
First Quarter Product and Pipeline Update
Key development milestones:
Clinical Program
Indication
Projected Milestone
Repatha
Hyperlipidemia
Regulatory submissions (CV outcomes data)
KYPROLIS
Relapsed or refractory multiple myeloma
Phase 3 study initiation with DARZALEX Q2 ’17
XGEVA
Prevention of SREs in multiple myeloma
Regulatory reviews
EVENITY (romosozumab)†
Postmenopausal osteoporosis
July 19, 2017, PDUFA target action date in U.S.
Active controlled Phase 3 fracture data Q2 2017*
Erenumab (AMG 334)
Migraine prevention
Regulatory submissions
ABP 215
(biosimilar bevacizumab)
Oncology
Regulatory reviews
Sept. 14, 2017, BsUFA target action date in U.S.
ABP 980
(biosimilar trastuzumab)
Breast cancer
U.S. regulatory submission
†Trade name provisionally approved by FDA; CV = cardiovascular; SRE = skeletal-related event; PDUFA = Prescription Drug User Fee Act; BsUFA = Biosimilar User Fee Act; *Event driven study
The Company provided the following updates on selected product and pipeline programs:
Repatha
In February, the European Commission (EC) approved a new 420 mg single-dose delivery option for Repatha.
In March, positive Phase 3 data from a cardiovascular outcomes study and a cognitive function study were presented at the American College of Cardiology 66th Annual Scientific Session.
KYPROLIS
In February, the Phase 3 ENDEAVOR study showed KYPROLIS and dexamethasone reduced the risk of death by 21 percent and extended overall survival by an additional 7.6 months compared to Velcade (bortezomib) and dexamethasone in relapsed or refractory multiple myeloma patients.
XGEVA
In April, a supplemental Biologics License Application (sBLA) was submitted to the U.S. Food and Drug Administration (FDA) and an application for a variation to the marketing authorization was submitted to the European Medicines Agency (EMA) for the prevention of SREs in patients with multiple myeloma.
BLINCYTO
In March, FDA accepted the sBLA for priority review for BLINCYTO to include overall survival data from the Phase 3 TOWER study. The application also included new data supporting the treatment of patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
EVENITY
Primary analysis of an event driven active controlled Phase 3 fracture study (ARCH) in postmenopausal women with osteoporosis is expected in Q2 2017.
Erenumab
Regulatory submissions for migraine prevention are expected in Q2 2017.
CNP520
In February, Phase 3 enrollment commenced for CNP520, a small molecule beta-site amyloid precursor protein-cleaving enzyme-1 (BACE) inhibitor for the potential treatment of Alzheimer’s disease.
Parsabiv (etelcalcetide)
In February, FDA approved Parsabiv for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
AMG 157/MEDI9929 (tezepelumab)
In February, tezepelumab demonstrated a significant reduction in the rate of asthma exacerbations compared to placebo over the 52-week treatment period in patients with severe asthma in a Phase 2b study.
AMGEVITA (biosimilar adalimumab)
In March, EC granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications. AMGEVITA is authorized for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The EC also approved AMGEVITA for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
ABP 980 (biosimilar trastuzumab)
In March, a Marketing Authorization Application was submitted to the EMA.
Erenumab and CNP520 are developed in collaboration with Novartis AG
EVENITY trade name is provisionally approved by FDA
EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Tezepelumab is developed in collaboration with AstraZeneca
AMGEVITA is registered in the U.S. as AMJEVITA
Velcade is a registered trademark of Millennium Pharmaceuticals, Inc.
Author: [email protected]
Circle Pharma Announces Expansion of Series A Financing and Appointment of James C. Lu to Its Board
On April 25, 2017 Circle Pharma , Inc. reported that it has completed an expansion of its Series A financing, with new investors WI Harper Group, Elements Partners, LLC, Whitesun Healthcare Ventures Limited and LifeForce Capital joining the round (Press release, Circle Pharma, APR 25, 2017, View Source [SID1234635668]). Mission Bay Capital led Circle’s Series A, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors subscribing at the initial close. With this subsequent closing, a total of approximately $6.5M of shares of Circle’s Series A Preferred Stock has been issued in the Series A financing.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are gratified to have this new group of high-caliber investors joining our first equity financing," said David J. Earp, J.D., Ph.D., Circle’s president and CEO. "The funds will support Circle’s platform development and our therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. This is an exciting time for Circle. We are adding new targets to our pipeline, including MCL1 and the substrate binding site of cyclinA / cdk2, both of which are important oncology targets that have proven challenging for small molecule drug development. Our chemistry process development work has recently successfully achieved key steps required for a more highly automated synthesis platform. Finally, with support from Pfizer, we are building a physical library of macrocycles which are predicted to have optimized permeability. This library will complement our rational design/virtual library screening approach. We will begin synthesis of the physical library shortly, enabling us to deliver it to Pfizer, and potentially other collaborators, for screening use later this year. We are especially delighted to welcome James Lu to our board in connection with this expanded Series A investment. He brings deep experience building high-growth, global companies both as an investor and in management roles."
Mr. Lu is a Managing Director of WI Harper, a cross border venture capital firm investing in leading healthcare and technology startups in the U.S. and China. Previously, Mr. Lu co-founded and was a General Partner of iD Ventures America (formerly Acer Technology Ventures), which managed several funds that were early investors in companies such as iRobot (NASDAQ:IRBT); Harmonix Music (acquired by MTV/Viacom (NYSE:VIA)); and Monolithic Power Systems (NASDAQ:MPWR). In prior roles, Mr. Lu was General Counsel of the Acer Group and earlier was a corporate and commercial attorney with the McCutchen law firm in San Francisco and a banker at JP Morgan in New York. Mr. Lu graduated with a BA from Yale College, an MBA from Harvard Business School and a JD from UC Berkeley School of Law.
Peter Liu, Founder and Chairman of WI Harper Group commented, "We are seeing excellent opportunities for investing in ground-breaking life science companies that are advancing new technologies and addressing unsolved problems. Circle Pharma is one such company; we are pleased to participate in their Series A financing and look forward to building a strong relationship with the management team and the other investors."
"Completion of Circle’s Series A financing strengthens Circle’s investor base and brings additional depth on the technical side, relations with strategic partners and, with WI Harper and Elements, connections to activities and initiatives outside of the U.S., and especially in key Asia markets," said Douglas Crawford, Ph.D., managing director of Mission Bay Capital.
About Macrocyclic Peptides
Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle is applying its ability to design potent macrocycles with intrinsic cell permeability and drug-like characteristics to unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches.
10-Q – Quarterly report [Sections 13 or 15(d)]
Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
TESSA THERAPEUTICS AND VYRIAD FORM PARTNERSHIP TO CREATE NEXT GENERATION OF CANCER IMMUNOTHERAPY TREATMENTS
On April 25, 2017 Tessa Therapeutics, an immunotherapy company dedicated to revolutionizing the treatment of cancer, and Vyriad, an oncolytic virotherapy company using engineered viruses to destroy tumors and boost the antitumor immune response, reported a collaboration that will enable Tessa and Vyriad to investigate T cell and oncolytic virus combination therapies (Press release, Vyriad, APR 25, 2017, View Source [SID1234527874]). The combination of these two therapies is highly synergistic and has the potential to target a wide range of solid tumors with increased efficacy.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Tessa and Vyriad have signed a collaboration agreement to combinae Tessa’s HPV-specific T cells with Vyriad’s vesicular stomatitis virus (VSV) for the treatment of HPV-associated cancers such as cervical as well as head and neck cancers. Tessa is currently employing its HPV-specific T Cell technology in an FDA Phase I trial targeting these cancers, and aims to commence Phase II trials in 2017/2018. Vyriad is currently testing its oncolytic VSV technology in FDA Phase I trials. Additionally, Vyriad plans to clinically test a virus that has been engineered to drive proliferation of HPV-specific T cells in early 2018.
Whilst oncolytic viruses are known for their ability to specifically infect and destroy tumors, Vyriad’s oncolytic viruses have been engineered to express antigens to improve the immune response against the tumor. This increased antigen expression is expected to significantly enhance the efficacy of Tessa’s VSTs by improving their ability to recognize, target, and destroy cancer cells, thus making the combination of both treatments highly synergistic. Furthermore, oncolytic viruses can be engineered to express viral tumor antigens in nonvirus associated cancers, hence widening the potential range of cancers that can be targeted by Tessa’s VST-based treatments.
Andrew Khoo, co-founder and CEO of Tessa Therapeutics, commented on the partnership "We are constantly looking for ways to expand the efficacy and potential applications of our cancer treatments to benefit as many patients as possible. The combination of VSTs with oncolytic viruses is a novel approach that is entirely aligned with our philosophy of redirecting the body’s highly effective anti-viral immune response to target and destroy solid tumors."
Dr Stephen Russell, co-Founder, President and CEO of Vyriad, said "Through this partnership, Tessa and Vyriad can build on each company’s expertise to develop treatments that are more potent with broader applications. The use of engineered viruses, together with VSTs, is highly synergistic and has the potential to benefit a greater range of patients in areas of significant unmet medical need."
IMMUNE THERAPEUTICS, INC. FILES LODONAL NEW DRUG APPLICATION IN KENYA
On April 25, 2017 Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, reported it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator (Press release, TNI BioTech, APR 25, 2017, View Source [SID1234518733]).
"This NDA submission initiates the process we believe will result in broad access to our therapy for those suffering from immune deficiency disease and cancer." said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. "We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application."
A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.
Omaera Pharmaceuticals, Ltd. and GB Pharma Holding supported this filing. "Without their support, the fast track of this process would not have been possible." noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. "The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement." concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month." notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC.