Q4 '19 EARNINGS CALL
JANUARY 30, 2020
SAFE HARBOR STATEMENT
This presentation contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations with any other company, including BeiGene, Ltd., or the Otezla® (apremilast) acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Please refer to Amgen's most recent Forms 10-K,10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of January 30, 2020 and expressly disclaims any duty to update information contained in this presentation.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
This presentation includes GAAP and non-GAAP financial measures. In accordance with the requirements of SEC Regulation G, reconciliations between these two measures, if these slides are in hard copy, accompany the hard copy presentation or, if these slides are delivered electronically, are available on the Company's website at www.amgen.com within the Investors section.
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 2 |
materially; Amgen disclaims any duty to update. | |
AGENDA
Introduction | Arvind Sood | ||
Opening Remarks | Bob Bradway | ||
Q4 '19 and FY '19 Business Results | Peter Griffith | ||
Global Commercial Review | Murdo Gordon | ||
R&D Review | David Reese | ||
Q&A | All | ||
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 3 |
materially; Amgen disclaims any duty to update. | |
INVESTING FOR LONG-TERM GROWTH
- Entering a period of revenue growth in 2020
- Reshaping our product portfolio with a focus on driving volume growth
- Expanding our geographic footprint-joint venture with Astellas reverts back to Amgen this year; BeiGene collaboration advances our entry into China
- Exceeding $1 billion in biosimilars sales this year
- Expecting important data from our innovative pipeline in 2020
- Engaging in disciplined and thoughtful capital allocation
- Continuing commitment to environmentally sustainable operations
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 4 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 AND FY '19 BUSINESS RESULTS
PETER GRIFFITH
EXECUTIVE VICE PRESIDENT AND CHIEF FINANCIAL OFFICER
NON-GAAP EPS UP 6% IN Q4 2019
$ Millions, Except Non-GAAP EPS
Item | Q4 '19 | Q4 '18 | B/(W) % | ||
Revenue | $6,197 | $6,230 | (1)% | ||
Product Sales | 5,881 | 6,001 | (2)% | ||
Other Revenues | 316 | 229 | |||
Non-GAAP Operating Expenses | 3,576 | 3,513 | (2)% | ||
Cost of Sales % of product sales | 790 | 13.4% | 819 | 13.6% | |
R&D % of product sales | 1,285 | 21.9% | 1,162 | 19.4% | |
SG&A % of product sales | 1,501 | 25.5% | 1,532 | 25.5% | |
Non-GAAP Operating Income % of product sales | 2,621 | 44.6% | 2,717 | 45.3% | (4)% |
Other Income/(Expense) | (65) | (197) | |||
Non-GAAP Net Income | $2,174 | $2,186 | (1)% | ||
Non-GAAP EPS | $3.64 | $3.42 | 6% | ||
Average Shares (millions) | 598 | 640 | 7% | ||
Non-GAAP Tax Rate | 14.9% | 13.3% | (1.6) pts | ||
All income statement items for Q4 '19 and/or Q4 '18, except revenue, other income/(expense) and average shares, are non-GAAP financial measures-if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 6 |
materially; Amgen disclaims any duty to update. | |
NON-GAAP EPS UP 3% IN 2019
$ Millions, Except Non-GAAP EPS
Item | FY '19 | FY '18 | B/(W) % | ||
Revenue | $23,362 | $23,747 | (2)% | ||
Product Sales | 22,204 | 22,533 | (1)% | ||
Other Revenues | 1,158 | 1,214 | |||
Non-GAAP Operating Expenses | 12,205 | 11,890 | (3)% | ||
Cost of Sales % of product sales | 3,065 | 13.8% | 3,001 | 13.3% | |
R&D % of product sales | 4,027 | 18.1% | 3,657 | 16.2% | |
SG&A % of product sales | 5,113 | 23.0% | 5,232 | 23.2% | |
Non-GAAP Operating Income % of product sales | 11,157 | 50.2% | 11,857 | 52.6% | (6)% |
Other Income/(Expense) | (536) | (786) | |||
Non-GAAP Net Income | $9,028 | $9,573 | (6)% | ||
Non-GAAP EPS | $14.82 | $14.40 | 3% | ||
Average Shares (millions) | 609 | 665 | 8% | ||
Non-GAAP Tax Rate | 15.0% | 13.5% | (1.5) pts | ||
All income statement items for FY '19 and/or FY '18, except revenue and average shares, are non-GAAP financial measures-if this slide is in hard copy, see reconciliations
accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 7 |
materially; Amgen disclaims any duty to update. | |
STRONG BALANCE SHEET WITH FREE CASH FLOW OF $8.5B IN 2019
$ Billions, Except Dividends Paid per Share
Cash Flow Data | FY '19 | FY '18 |
Capital Expenditures | $0.6 | $0.7 |
Free Cash Flow* | 8.5 | 10.6 |
Share Repurchases | 7.6 | 17.9 |
Dividends Paid | 3.5 | 3.5 |
Dividends Paid Per Share | $5.80 | $5.28 |
Balance Sheet Data | FY '19 | FY '18 |
Cash and Investments | 8.9 | 29.3 |
Debt Outstanding | 29.9 | 33.9 |
*Non-GAAP financial measure-if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 8 |
materially; Amgen disclaims any duty to update. | |
2020 GUIDANCE
Guidance | |||
Revenue | $25.0B-$25.6B | ||
Non-GAAP EPS* | |||
$14.85-$15.60 | |||
Non-GAAP Tax Rate* | 13.5%-14.5% | ||
Capital Expenditures | |||
~ $700M | |||
*Non-GAAP financial measure-if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, or amounts pertain to previously issued financial guidance, see reconciliations available at: www.amgen.com within the Investors section
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 9 |
materially; Amgen disclaims any duty to update. | |
GLOBAL COMMERCIAL REVIEW
MURDO GORDON
EXECUTIVE VICE PRESIDENT, GLOBAL COMMERCIAL OPERATIONS
Q4 '19 GLOBAL COMMERCIAL REVIEW
$ Millions, Net Sales | Q4 '19 | Q4 '18 | YoY r | ||||
U.S. | ROW | Total | Total | Total | |||
Prolia® | $499 | $253 | $752 | $655 | 15% | ||
EVENITY® | 27 | 58 | 85 | - | NM | ||
Repatha® | 117 | 83 | 200 | 159 | 26% | ||
Aimovig® | 98 | - | 98 | 95 | 3% | ||
Parsabiv® | 156 | 23 | 179 | 120 | 49% | ||
Otezla® | 139 | 39 | 178 | - | NM | ||
Enbrel® | 1,306 | 40 | 1,346 | 1,315 | 2% | ||
KYPROLIS® | 171 | 95 | 266 | 251 | 6% | ||
XGEVA® | 366 | 123 | 489 | 456 | 7% | ||
Vectibix® | 80 | 102 | 182 | 168 | 8% | ||
Nplate® | 125 | 85 | 210 | 182 | 15% | ||
BLINCYTO® | 50 | 30 | 80 | 63 | 27% | ||
Neulasta® | 583 | 82 | 665 | 1,169 | (43%) | ||
NEUPOGEN® | 41 | 21 | 62 | 75 | (17%) | ||
EPOGEN® | 210 | - | 210 | 264 | (20%) | ||
Aranesp® | 180 | 247 | 427 | 474 | (10%) | ||
Sensipar®/Mimpara® | 36 | 71 | 107 | 448 | (76%) | ||
KANJINTI™ | 79 | 24 | 103 | 23 | NM | ||
MVASI™ | 79 | 5 | 84 | - | NM | ||
AMGEVITA™ | - | 71 | 71 | 11 | NM | ||
Other* | 27 | 60 | 87 | 73 | 19% | ||
Total Product Sales | $4,369 | $1,512 | $5,881 | $6,001 | (2%) | ||
Total Revenue | $6,197 | $6,230 | (1%) |
NM = not meaningful
*Other includes GENSENTA, Bergamo, Corlanor® and IMLYGIC®
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 11 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 PRODUCT SALES
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||
Total Growth | (2%) | 8% | |||
ROW | Units | 3% | 7% | ||
U.S. | Inventory | 0% | 2% | ||
6,001 | 5,286 | 5,574 | 5,463 | 5,881 | |
1,346 | |||||
1,512 | |||||
1,432 | 1,434 | ||||
1,295 | |||||
4,655 | 3,991 | 4,142 | 4,029 | 4,369 | |
FY 2019 Highlights
- For the full year, unit volume grew 3%
- Launched EVENITY® for postmenopausal osteoporosis across multiple markets
- Launched our first biosimilars in the U.S. - KANJINTI™ and MVASI™
- Closed deals with Celgene to acquire Otezla® and with BeiGene to expand oncology presence in China
- For the full year, international sales grew 14%, excluding the impact of foreign exchange,* driven by 19% volume growth
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Non-GAAP financial measure-if this slide is in hard copy, see reconciliations accompanying the presentation, or if this slide is delivered electronically, see reconciliations available at: www.amgen.com within the Investors section
Note: Inventory represents wholesaler and, based on prescription data for ENBREL, end-user inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 12 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 PROLIA® SALES GREW 15% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||
Total Growth | 15% | 19% | |||
ROW | Units | 14% | 15% | ||
U.S. | Inventory | 1% | 4% | ||
698 | 752 | ||||
655 | 630 | ||||
592 | |||||
253 | |||||
240 | |||||
225 | 205 | ||||
202 | |||||
430 | 390 | 458 | 425 | 499 | |
Highlights
- Strong Q4 performance with 15% sales growth YoY driven by higher unit demand
- QoQ increase follows typical Prolia® seasonality
Q4 '18 Q1 '19 Q2 '19 Q3 '19 Q4 '19
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 13 |
materially; Amgen disclaims any duty to update. | |
EVENITY® GENERATED $189M IN SALES IN 2019
$ Millions, Net Sales
Q4 '19 | QoQ | |||||||||
Total Growth | 44% | |||||||||
ROW | Units | 42% | ||||||||
U.S. | Inventory | 5% | ||||||||
85 | ||||||||||
59 | ||||||||||
58 | ||||||||||
28 | 47 | |||||||||
17 | 25 | |||||||||
0 | 12 | 27 | ||||||||
3 | ||||||||||
Q4 '18 | Q1 '19 | Q2 '19 | Q3 | '19 | Q4 '19 |
Highlights
- Majority of Q4 sales were in Japan
- Approved in the EU for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture
Note: Inventory represents wholesaler inventories
EVENITY® is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 14 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 REPATHA® SALES GREW 26% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |
Total Growth | 26% | 19% | |
ROW | Units | 67% | 11% |
U.S. | Inventory | (8%) | (1%) |
200 | ||
159 | 152 | 168 |
83 | ||
141 | ||
55 | 61 | 83 |
58 |
Highlights
- Repatha® is the U.S. PCSK9 leader with 66% share of total prescriptions and 75% share of new prescriptions
- YoY growth driven primarily by higher unit demand, offset partially by net selling price*
- Blended U.S. net selling price* declined YoY, relatively stable QoQ
104 | 83 | 91 | 85 | 117 |
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
- Original list price version discontinued December 31, 2019
Note: Inventory represents wholesaler inventories; PCSK9 = proprotein convertase subtilisin/kexin type 9 *Net selling price represents the impact of list price changes as well as contracting and access changes
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 15 |
materially; Amgen disclaims any duty to update. | |
AIMOVIG® CONTINUES TO TRANSFORM THE TREATMENT OF MIGRAINE
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |
Total Growth | 3% | 48% | |
U.S. | Units | 27% | 9% |
Inventory | (4%) | 1% | |
95 | 98 | ||
83 |
59 | 66 |
Highlights
- Four million migraine patients eligible for anti-CGRP treatment
- Aimovig® is the market leader with 48% of total prescriptions
- Paid demand > 80% in Q4
- As of January 1 with the CVS addition, 92% of lives will be covered
- YoY comparison adversely impacted by
- $20M of favorable changes in accounting estimates in Q4 2018
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
CGRP = calcitonin gene-related peptide; Aimovig® is developed in collaboration with Novartis
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 16 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 PARSABIV® SALES GREW 49% YOY
$ Millions, Net Sales
Highlights
ROW U.S.
Q4 '19 YoY QoQ
Total Growth 49% 14%
Units 67% 12%
Inventory (4%) 1%
• | Strong utilization at independent and |
midsize dialysis providers | |
• | YoY growth driven primarily by higher |
168
179
unit demand, offset partially by net |
120 126
1217
108 109
20 157 23
20
148 137 156
selling price* |
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Net selling price represents the impact of list price changes as well as contracting and access changes Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 17 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 OTEZLA® SALES OF $178M
$ Millions, Net Sales
ROW
U.S.
178
39
139
Highlights
-
Acquisition closed on November 21, 2019
- Amgen sales were $178 million for the ~ 5 weeks of ownership in 2019 - Focus on seamless integration
-
Expect continuation of historical pattern of lower Q1 sales
vs. subsequent quarters
Q2 '19Q3 '19Q4 '19
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 18 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 ENBREL® SALES GREW 2% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | ||||||||||||
Total Growth | 2% | (1%) | ||||||||||||
ROW | Units | (5%) | (3%) | |||||||||||
U.S. | Inventory | 0% | 4% | |||||||||||
1,315 | 1,363 | 1,366 | 1,346 | |||||||||||
48 | 43 | |||||||||||||
40 | ||||||||||||||
52 | 1,151 | |||||||||||||
45 | ||||||||||||||
1,263 | 1,106 | 1,315 | 1,323 | 1,306 | ||||||||||
Highlights
- YoY growth driven primarily by favorable changes in accounting estimates and higher net selling price,* offset partially by lower unit demand
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Net selling price represents the impact of list price changes as well as contracting and access changes Note: Inventory represents wholesaler and, based on prescription data, end-user inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 19 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 HEMATOLOGY/ONCOLOGY* SALES GREW 10% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||
Total Growth | 10% | 1% | |||
ROW | Units | 8% | 0% | ||
U.S. | Inventory | 0% | 0% | ||
1,133 | 1,157 | 1,257 | 1,234 | 1,241 | |
403 | 405 | 459 | 458 | 437 | |
Highlights
- Double-digitYoY growth driven by unit volume growth
- Sales totaled $4.9 billion in 2019, 10% YoY growth versus 2018
730 752 798 776 804
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Includes XGEVA®, KYPROLIS®, Nplate®, Vectibix®, BLINCYTO® and IMLYGIC® Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 20 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 XGEVA® SALES GREW 7% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||
Total Growth | 7% | 3% | |||
ROW | Units | 4% | 0% | ||
U.S. | Inventory | 0% | 1% | ||
456 | 471 | 499 | 476 | 489 | |
112 | 115 | 120 | 120 | 123 | |
Highlights
- YoY growth driven primarily by higher unit demand and, to a lesser extent, higher net selling price*
344 356 379 356 366
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler and, based on prescription data, end-user inventories
*Net selling price represents the impact of list price changes as well as contracting and access changes
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 21 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 KYPROLIS® SALES GREW 6% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||
Total Growth | 6% | 0% | |||
ROW | Units | 6% | 1% | ||
U.S. | Inventory | (1%) | 0% | ||
251 | 245 | 267 | 266 | 266 | |
98 | 91 | 101 | 103 | 95 | |
Highlights
- YoY growth driven by higher unit demand
- Breadth of prescribers continues to increase
153 | 154 | 166 | 163 | 171 |
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 22 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 NPLATE® SALES GREW 15% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | ||||
Total Growth | 15% | 8% | ||||
ROW | Units | 12% | 7% | |||
U.S. | Inventory | 2% | 1% | |||
201 | 195 | 210 | ||||
182 | 189 | |||||
70 | 75 | 79 | 76 | 85 | ||
112 114 122 119 125
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.
Highlights
- YoY growth driven primarily by higher unit demand
- Launched 125 mcg presentation in support of pediatric thrombocytopenia
- Recent FDA approval for earlier use in adults with immune thrombocytopenia
23
Q4 '19 NEULASTA® SALES DECREASED 43% YOY
$ Millions, Net Sales
Highlights
ROW
U.S.
1,169
157 1,021
128
1,012 893
Q4 '19 YoY QoQ
Total Growth (43%) (6%)
Units (27%) (6%)
Inventory (1%) 3%
824
105 | 711 | 665 | |||
92 | |||||
719 | 82 | ||||
619 | |||||
583 | |||||
- YoY sales decrease driven by impact of biosimilar competition on unit demand and lower net selling price*
- YoY comparison adversely impacted by $55M U.S. Biomedical Advanced Research and Development Authority (BARDA) order in Q4 2018
- Neulasta® exited Q4 with 74% share of the long-acting segment
- Onpro® exited Q4 with 55% share
- Q1 2019 included a $98M BARDA order not expected to repeat in 2020
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Net selling price represents the impact of list price changes as well as contracting and access changes Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 24 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 EPOGEN® SALES DECLINED 20% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | ||
Total Growth | (20%) | (2%) | ||
U.S. | Units | (10%) | (4%) | |
Inventory | 0% | (2%) | ||
264 | ||||
219 | 223 | 215 | 210 |
Highlights
- YoY sales decline driven by lower net selling price* and unit demand
- Net selling price* trend will continue due to DaVita contract
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Net selling price represents the impact of list price changes as well as contracting and access changes Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 25 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 ARANESP® SALES DECLINED 10% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | ||
Total Growth | (10%) | (6%) | ||
ROW | Units | (5%) | 1% | |
U.S. | Inventory | (2%) | (1%) | |
474 | 436 | 452 | 427 | |
414 | ||||
246 | 244 | 248 | ||
232 | 247 | |||
Highlights
- YoY decline driven by the impact of competition on unit demand and lower net selling price* as well as unfavorable changes in inventory
228 | 182 | 192 | 204 | 180 |
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
*Net selling price represents the impact of list price changes as well as contracting and access changes Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 26 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 SENSIPAR® SALES DECREASED 76% YOY
$ Millions, Net Sales
Q4 '19 | YoY | QoQ | |||||||
Total Growth | (76%) | (2%) | |||||||
ROW | Units | (68%) | (9%) | ||||||
U.S. | Inventory | 0% | 4% | ||||||
448 | |||||||||
81 | |||||||||
213 | |||||||||
367 | 78 | 122 | 109 | 107 | |||||
135 | 79 | 71 | 71 | ||||||
43 | 38 | 36 | |||||||
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.
Highlights
- YoY decrease driven by the impact of competition on unit demand
- In 2020, expect U.S. trends to continue; potential declines ex-U.S. due to expiries of supplemental patent protections in Europe
27
Q4 '19 KANJINTI™ SALES
$ Millions, Net Sales
Q4 '19 | QoQ | ||||||||
Total Growth | 49% | ||||||||
ROW | Units | 52% | |||||||
U.S. | Inventory | 0% | |||||||
103 | |||||||||
24 | |||||||||
69 | |||||||||
30 | |||||||||
23 | 24 | 30 | 79 | ||||||
39 | |||||||||
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.
Highlights
- Strong uptake in the U.S., with 15% exit share of the trastuzumab market
- Expect several additional U.S. biosimilar competitor launches in first half of 2020
28
Q4 '19 MVASI™ SALES
$ Millions, Net Sales
Q4 '19 | QoQ | ||||||
Total Growth | 95% | ||||||
ROW | Units | 109% | |||||
U.S. | Inventory | (16%) | |||||
84 | |||||||
5 | |||||||
43 | |||||||
1 | 79 | ||||||
42 | |||||||
Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.
Highlights
- Strong uptake in the U.S., with 17% exit share of the bevacizumab marketplace
- Broad payer coverage, with ~ 90% supported provider adoption
- Now facing additional U.S. biosimilar competitor
29
Q4 '19 AMGEVITA™ SALES
$ Millions, Net Sales
Q4 '19 | QoQ | |
Total Growth | 16% | |
ROW | Units | 22% |
Inventory | 0% | |
71
61
52
31
11
Q4 '18 | Q1 '19 | Q2 '19 | Q3 '19 | Q4 '19 |
Note: Inventory represents wholesaler inventories
Provided January 30, 2020, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may vary materially; Amgen disclaims any duty to update.
Highlights
- AMGEVITA™ is the adalimumab biosimilar market leader in many European markets
30
R&D REVIEW
DAVID REESE, M.D.
EXECUTIVE VICE PRESIDENT, RESEARCH AND DEVELOPMENT
Q4 '19 R&D UPDATE
Inflammation
- Otezla®
- Data from the Phase 3 study in patients with mild-to-moderate psoriasis expected by mid-year
- Label update with Phase 3 scalp psoriasis data under review by FDA-April 2020 PDUFA target action date
- Under regulatory review in EU for Behçet's disease
- Tezepelumab-TSLPmonoclonal antibody
- Phase 3 data in severe uncontrolled asthma expected end of 2020
Bone
-
EVENITY®
- Approved in EU for treatment of severe osteoporosis in postmenopausal women at high risk
of fracture
PDUFA = Prescription Drug User Fee Act; TSLP = thymic stromal lymphopoietin
Tezepelumab is being developed in collaboration with AstraZeneca; EVENITY® is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 32 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 R&D UPDATE
Oncology
- AMG 510-KRAS G12C inhibitor
- Enrollment completed for potentially pivotal Phase 2 NSCLC monotherapy study-initial data expected this year
- Enrolling additional CRC patients in Phase 2 monotherapy study
- Ongoing Phase 1 monotherapy study also enrolling treatment-naïve NSCLC patients
- Additional Phase 1 monotherapy data in multiple solid tumor types expected in 2020
- Initial Phase 1 combination data with KEYTRUDA® (pembrolizumab) in NSCLC expected in 2020
- Enrolling Phase 1b NSCLC/CRC study in combination with MEK inhibition
- Entered strategic collaborations with Guardant Health, Inc. and QIAGEN N.V. to develop blood- and tissue-based companion diagnostics, respectively
KRAS G12C = Kirsten rat sarcoma viral oncogene homolog with G12C mutation; NSCLC = non-small cell lung cancer; CRC = colorectal cancer;
MEK = mitogen-activated protein kinase kinase; KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
Provided January 30, 2020, as part of an oral presentation and is qualified
by such, contains forward-looking statements, actual results may vary | 33 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 R&D UPDATE
Oncology (continued)
-
AMG 701-BCMAHLE-BiTE® molecule
- Data from first-in-human dose escalation study expected in 2020 - AMG 199-MUC17HLE-BiTE® molecule
• First-in-human study enrolling patients with MUC17 positive gastric cancer
- KYPROLIS®
- Supplemental New Drug Application submitted to FDA based on Phase 3 CANDOR data
- Under regulatory review in China for relapsed and refractory multiple myeloma
- BLINCYTO®
- Under priority review in China for adult relapsed or refractory B-cell ALL
BCMA = B-cell maturation antigen; HLE = half-life extended; BiTE® = bispecific T-cell engager; MUC17 = mucin-17; ALL = acute lymphoblastic leukemia
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 34 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 R&D UPDATE
Cardiovascular
- Omecamtiv mecarbil-cardiac myosin activator
- Data from the event-driven Phase 3 GALACTIC-HF cardiovascular outcomes study expected
Q4 '20
- Data from the event-driven Phase 3 GALACTIC-HF cardiovascular outcomes study expected
- AMG 890-Lipoprotein(a) siRNA
- Phase 2 study to begin in H1 2020
Biosimilars
- AVSOLA™ (infliximab-axxq)
- Approved in U.S. for all approved indications of Remicade®
- ABP 798 (biosimilar rituximab)
- U.S. Biologics License Application submitted
siRNA = short interfering ribonucleic acid; Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and
strategic support from Servier | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 35 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 EARNINGS CALL
JANUARY 30, 2020
RECONCILIATIONS
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 38 |
materially; Amgen disclaims any duty to update. | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 39 |
materially; Amgen disclaims any duty to update. | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 40 |
materially; Amgen disclaims any duty to update. | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 41 |
materially; Amgen disclaims any duty to update. | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 42 |
materially; Amgen disclaims any duty to update. | |
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 43 |
materially; Amgen disclaims any duty to update. | |
Amgen Inc.
International Sales Performance Adjusted for Foreign Exchange
Amgen has presented international sales performance excluding the impact of foreign exchange. This measure adjusts for the translation effect of changes in average foreign exchange rates between the current period and the corresponding period in the prior year. Amgen's calculation to adjust for the impact of foreign exchange results in prior period weighted-average, foreign exchange rates being applied to current period product sales. Amgen believes that excluding the impact of foreign exchange enhances an investor's overall understanding of the financial performance and prospects for the future of Amgen's core business activities by facilitating comparisons of results of core business operations among current, past and future periods.
Provided January 30, 2020, as part of an oral presentation and is qualified | |
by such, contains forward-looking statements, actual results may vary | 44 |
materially; Amgen disclaims any duty to update. | |
Q4 '19 EARNINGS CALL
JANUARY 30, 2020
Attachments
- Original document
- Permalink
Disclaimer
Amgen Inc. published this content on 30 January 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 January 2020 22:39:04 UTC