RAD Increases Ownership in Radiopharm Ventures to 75%

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical needs, is pleased to announce that it has increased its ownership stake in Radiopharm Ventures, LLC, a joint venture created with The University of Texas MD Anderson Cancer Center, from 51% to 75%.

Radiopharm Ventures, LLC, is a joint venture created in Q3 2022 between MD Anderson and Radiopharm Theranostics
Leading candidate B7H3 mAb is successfully completing preclinical studies
B7H3 Phase I therapeutic clinical trial planned to start in H1 CY2025
B7H3 Phase 1 will be the first clinical trial globally targeting B7H3 as with a systemic radiopharmaceutical
Two additional preclinical Radiopharm Ventures’ assets show early positive results – move to final candidate selection

The move to an increased ownership percentage comes as the joint venture continues to show promising progress in its cancer therapeutic pipeline, including the advancement of its leading B7H3 candidate and other preclinical assets.

B7-H3 is an immune checkpoint protein that is very infrequently seen in the majority of healthy cells but it is consistently abnormally overexpressed in the majority of cancer tissues. High expression of B7H3 in cancer is associated with greater tumor size and lymphatic invasion.

The B7H3 monoclonal antibody (mAb) lead candidate is successfully completing preclinical studies.

The company plans to initiate a Phase I therapeutic trial in the first half of calendar 2025, making a significant step toward clinical application.

Additionally, two other preclinical candidates have demonstrated early positive results and have progressed towards final candidate selection, with potential applications across multiple solid tumour types.

To support these advancements and its ownership percentage increase to 75%, Radiopharm has committed an additional USD$4.0 million to the joint venture, to cover future preclinical and clinical expenses.

Radiopharm and MD Anderson launched Radiopharm Ventures, LLC in September 2022 to develop novel radiopharmaceutical products for cancer treatment. The joint venture leverages MD Anderson’s expertise in antigen discovery and molecular imaging alongside Radiopharm’s capabilities in developing radiopharmaceutical therapies.

Riccardo Canevari, CEO & Managing Director of Radiopharm, commented: "We are encouraged by the progress to date within Radiopharm Ventures. The increased ownership by RAD, coupled with the advancements in the associated programs, positions us well to enter a Phase 1 clinical trial with B7H3 next year.”

Click here for the full ASX Release

This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.

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RAD:AU

AMGEN REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS

Amgen (NASDAQ: AMGN) today announced financial results for the second quarter 2024.

"With a strong, balanced portfolio of in-market products and a rapidly advancing pipeline of innovative medicines, we are confident in our ability to deliver attractive long-term growth," said Robert A. Bradway , chairman and chief executive officer.

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$Millions, except percentages	Q2 '24			Q2 '23	YOYΔ
	U.S	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 270	$ 262	$ 532	$ 424	25 %
EVENITY ^®	281	110	391	281	39 %
Prolia ^®	770	395	1,165	1,028	13 %
BLINCYTO ^®	165	99	264	206	28 %
Vectibix ^®	133	137	270	248	9 %
KYPROLIS ^®	240	137	377	346	9 %
LUMAKRAS ^® /LUMYKRAS ^™	55	30	85	77	10 %
XGEVA ^®	399	163	562	530	6 %
Nplate ^®	214	132	346	310	12 %
IMDELLTRA ^™	12	—	12	—	N/A
MVASI ^®	100	57	157	197	(20 %)
TEZSPIRE ^®	234	—	234	133	76 %
Otezla ^®	432	112	544	600	(9 %)
Enbrel ^®	902	7	909	1,068	(15 %)
AMJEVITA ^® /AMGEVITA ^™(1)	(9)	142	133	150	(11 %)
TEPEZZA ^®(2)	478	1	479	—	N/A
KRYSTEXXA ^®(2)	294	—	294	—	N/A
UPLIZNA ^®(2)	77	15	92	—	N/A
TAVNEOS ^®	61	10	71	30	*
Ultra rare products ⁽²⁾	175	12	187	—	N/A
EPOGEN ^®	32	—	32	61	(48 %)
Aranesp ^®	91	257	348	365	(5 %)
Parsabiv ^®	67	39	106	87	22 %
Neulasta ^®	75	30	105	236	(56 %)
Other products ⁽³⁾	292	54	346	306	13 %
Total product sales	$ 5,840	$ 2,201	$ 8,041	$ 6,683	20 %

*Change in excess of 100%
N/A = not applicable
⁽¹⁾ U.S AMJEVITA product sales for the three months ended June 30, 2024, were impacted by unfavorable changes to estimated sales deductions
⁽²⁾ Horizon-acquired products, and the Ultra rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , BUPHENYL ^® and QUINSAIR ^®
⁽³⁾ Consists of (i) KANJINTI ^® , Aimovig ^® , RIABNI ^® , Corlanor ^® , NEUPOGEN ^® , AVSOLA ^® , IMLYGIC ^® , BEKEMV ^™ , WEZLANA ^™ /WEZENLA ^™ and Sensipar ^® /Mimpara ^™ , where Biosimilars total $183 million in Q2 '24 and $130 million in Q2 '23; and (ii) Horizon-acquired products including RAYOS ^® and PENNSAID ^®

$Millions, except percentages	GAAP			Non-GAAP
	Q2 '24	Q2 '23	YOYΔ	Q2 '24	Q2 '23	YOYΔ
Cost of Sales	$ 3,236	$ 1,813	78 %	$ 1,406	$ 1,142	23 %
% of product sales	40.2 %	27.1 %	13.1 pts	17.5 %	17.1 %	0.4 pts
Research & Development	$ 1,447	$ 1,113	30 %	$ 1,423	$ 1,092	30 %
% of product sales	18.0 %	16.7 %	1.3 pts	17.7 %	16.3 %	1.4 pts
Selling, General & Administrative	$ 1,785	$ 1,294	38 %	$ 1,686	$ 1,237	36 %
% of product sales	22.2 %	19.4 %	2.8 pts	21.0 %	18.5 %	2.5 pts
Other	$ 11	$ 82	(87 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,479	$ 4,302	51 %	$ 4,515	$ 3,471	30 %

Operating Margin
operating income as % of product sales	23.7 %	40.2 %	(16.5) pts	48.2 %	52.6 %	(4.4) pts

Tax Rate	6.0 %	14.6 %	(8.6) pts	14.9 %	16.4 %	(1.5) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q2 '24	Q2 '23	YOYΔ
Operating Cash Flow	$ 2.5	$ 4.1	$ (1.7)
Capital Expenditures	$ 0.2	$ 0.3	$ 0.0
Free Cash Flow	$ 2.2	$ 3.8	$ (1.6)
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ 0.0	$ —	$ 0.0
Average Diluted Shares (millions)	541	537	4

Note: Numbers may not add due to rounding

$Billions	6/30/24	12/31/23	YTD Δ
Cash and Investments	$ 9.3	$ 10.9	$ (1.6)
Debt Outstanding	$ 62.6	$ 64.6	$ (2.0)

Note: Numbers may not add due to rounding

Amgen Inc.
Consolidated Statements of Income - GAAP
(In millions, except per-share data)
(Unaudited)

	Three months ended June 30,		Six months ended June 30,
	2024	2023	2024	2023
Revenues:
Product sales	$ 8,041	$ 6,683	$ 15,159	$ 12,529
Other revenues	347	303	676	562
Total revenues	8,388	6,986	15,835	13,091

Operating expenses:
Cost of sales	3,236	1,813	6,436	3,533
Research and development	1,447	1,113	2,790	2,171
Selling, general and administrative	1,785	1,294	3,593	2,552
Other	11	82	116	230
Total operating expenses	6,479	4,302	12,935	8,486

Operating income	1,909	2,684	2,900	4,605

Other income (expense):
Interest expense, net	(808)	(752)	(1,632)	(1,295)
Other (expense) income, net	(307)	(318)	(542)	1,746

Income before income taxes	794	1,614	726	5,056

Provision for income taxes	48	235	93	836

Net income	$ 746	$ 1,379	$ 633	$ 4,220

Earnings per share:
Basic	$ 1.39	$ 2.58	$ 1.18	$ 7.90
Diluted	$ 1.38	$ 2.57	$ 1.17	$ 7.86

Weighted-average shares used in calculation of earnings per share:
Basic	537	535	537	534
Diluted	541	537	541	537

Amgen Inc.
Consolidated Balance Sheets - GAAP
(In millions)

	June 30,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,301	$ 10,944
Trade receivables, net	6,934	7,268
Inventories	7,995	9,518
Other current assets	2,976	2,602
Total current assets	27,206	30,332

Property, plant and equipment, net	6,097	5,941
Intangible assets, net	30,172	32,641
Goodwill	18,616	18,629
Other noncurrent assets	8,816	9,611
Total assets	$ 90,907	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 15,989	$ 16,949
Current portion of long-term debt	5,528	1,443
Total current liabilities	21,517	18,392

Long-term debt	57,117	63,170
Long-term deferred tax liabilities	1,780	2,354
Long-term tax liabilities	2,205	4,680
Other noncurrent liabilities	2,363	2,326
Total stockholders' equity	5,925	6,232
Total liabilities and stockholders' equity	$ 90,907	$ 97,154

Shares outstanding	537	535

Amgen Inc.
GAAP to Non-GAAP Reconciliations
(Dollars in millions)
(Unaudited)

	Three months ended June 30,		Six months ended June 30,
	2024	2023	2024	2023
GAAP cost of sales	$ 3,236	$ 1,813	$ 6,436	$ 3,533
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,830)	(671)	(3,690)	(1,340)
Certain net charges pursuant to our restructuring and cost savings initiatives	—	—	—	(35)
Total adjustments to cost of sales	(1,830)	(671)	(3,690)	(1,375)
Non-GAAP cost of sales	$ 1,406	$ 1,142	$ 2,746	$ 2,158

GAAP cost of sales as a percentage of product sales	40.2 %	27.1 %	42.5 %	28.2 %
Acquisition-related expenses (a)	(22.7)	(10.0)	(24.4)	(10.7)
Certain net charges pursuant to our restructuring and cost savings initiatives	0.0	0.0	0.0	(0.3)
Non-GAAP cost of sales as a percentage of product sales	17.5 %	17.1 %	18.1 %	17.2 %

GAAP research and development expenses	$ 1,447	$ 1,113	$ 2,790	$ 2,171
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(24)	(4)	(50)	(18)
Certain net charges pursuant to our restructuring and cost savings initiatives	—	(17)	—	(17)
Total adjustments to research and development expenses	(24)	(21)	(50)	(35)
Non-GAAP research and development expenses	$ 1,423	$ 1,092	$ 2,740	$ 2,136

GAAP research and development expenses as a percentage of product sales	18.0 %	16.7 %	18.4 %	17.3 %
Acquisition-related expenses (b)	(0.3)	(0.1)	(0.3)	(0.2)
Certain net charges pursuant to our restructuring and cost savings initiatives	0.0	(0.3)	0.0	(0.1)
Non-GAAP research and development expenses as a percentage of product sales	17.7 %	16.3 %	18.1 %	17.0 %

GAAP selling, general and administrative expenses	$ 1,785	$ 1,294	$ 3,593	$ 2,552
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (c)	(99)	(57)	(195)	(91)
Non-GAAP selling, general and administrative expenses	$ 1,686	$ 1,237	$ 3,398	$ 2,461

GAAP selling, general and administrative expenses as a percentage of product sales	22.2 %	19.4 %	23.7 %	20.4 %
Acquisition-related expenses (c)	(1.2)	(0.9)	(1.3)	(0.8)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	21.0 %	18.5 %	22.4 %	19.6 %

GAAP operating expenses	$ 6,479	$ 4,302	$ 12,935	$ 8,486
Adjustments to operating expenses:
Adjustments to cost of sales	(1,830)	(671)	(3,690)	(1,375)
Adjustments to research and development expenses	(24)	(21)	(50)	(35)
Adjustments to selling, general and administrative expenses	(99)	(57)	(195)	(91)
Certain net charges pursuant to our restructuring and cost savings initiatives (d)	3	(26)	4	(167)
Certain other expenses (e)	(14)	(56)	(120)	(63)
Total adjustments to operating expenses	(1,964)	(831)	(4,051)	(1,731)
Non-GAAP operating expenses	$ 4,515	$ 3,471	$ 8,884	$ 6,755


	Three months ended June 30,		Six months ended June 30,
	2024	2023	2024	2023
GAAP operating income	$ 1,909	$ 2,684	$ 2,900	$ 4,605
Adjustments to operating expenses	1,964	831	4,051	1,731
Non-GAAP operating income	$ 3,873	$ 3,515	$ 6,951	$ 6,336

GAAP operating income as a percentage of product sales	23.7 %	40.2 %	19.1 %	36.8 %
Adjustments to cost of sales	22.7	10.0	24.4	11.0
Adjustments to research and development expenses	0.3	0.4	0.3	0.3
Adjustments to selling, general and administrative expenses	1.2	0.9	1.3	0.8
Certain net charges pursuant to our restructuring and cost savings initiatives (d)	0.0	0.4	0.0	1.3
Certain other expenses (e)	0.3	0.7	0.8	0.4
Non-GAAP operating income as a percentage of product sales	48.2 %	52.6 %	45.9 %	50.6 %

GAAP interest expense, net	$ (808)	$ (752)	$ (1,632)	$ (1,295)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (f)	—	333	—	456
Non-GAAP interest expense, net	$ (808)	$ (419)	$ (1,632)	$ (839)

GAAP other (expense) income, net	$ (307)	$ (318)	$ (542)	$ 1,746
Adjustments to other (expense) income, net
Interest income and other expenses on acquisition-related debt (f)	—	(288)	—	(294)
Net losses (gains) from equity investments (g)	405	718	915	(1,135)
Total adjustments to other (expense) income, net	405	430	915	(1,429)
Non-GAAP other income, net	$ 98	$ 112	$ 373	$ 317

GAAP income before income taxes	$ 794	$ 1,614	$ 726	$ 5,056
Adjustments to income before income taxes:
Adjustments to operating expenses	1,964	831	4,051	1,731
Adjustments to interest expense, net	—	333	—	456
Adjustments to other (expense) income, net	405	430	915	(1,429)
Total adjustments to income before income taxes	2,369	1,594	4,966	758
Non-GAAP income before income taxes	$ 3,163	$ 3,208	$ 5,692	$ 5,814

GAAP provision for income taxes	$ 48	$ 235	$ 93	$ 836
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	420	288	779	171
Other income tax adjustments (i)	4	2	(11)	(17)
Total adjustments to provision for income taxes	424	290	768	154
Non-GAAP provision for income taxes	$ 472	$ 525	$ 861	$ 990

GAAP tax as a percentage of income before taxes	6.0 %	14.6 %	12.8 %	16.5 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (h)	8.8	1.7	2.5	0.8
Other income tax adjustments (i)	0.1	0.1	(0.2)	(0.3)
Total adjustments to provision for income taxes	8.9	1.8	2.3	0.5
Non-GAAP tax as a percentage of income before taxes	14.9 %	16.4 %	15.1 %	17.0 %

GAAP net income	$ 746	$ 1,379	$ 633	$ 4,220
Adjustments to net income:
Adjustments to income before income taxes, net of the income tax effect	1,949	1,306	4,187	587
Other income tax adjustments (i)	(4)	(2)	11	17
Total adjustments to net income	1,945	1,304	4,198	604
Non-GAAP net income	$ 2,691	$ 2,683	$ 4,831	$ 4,824

Note: Numbers may not add due to rounding


(a)		The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions.

(b)		For the three and six months ended June 30, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three and six months ended June 30, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three and six months ended June 30, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition.

(d)		For the three and six months ended June 30, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(e)		For the three months ended June 30, 2024, the adjustments related primarily to changes in the fair values of contingent consideration liabilities. For the six months ended June 30, 2024, the adjustments related primarily to a net impairment charge for an in-process R&D asset and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three and six months ended June 30, 2023, the adjustments related primarily to a net impairment charge for an in-process R&D asset.

(f)		For the three and six months ended June 30, 2023, the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon.

(g)		For the three and six months ended June 30, 2024 and 2023, the adjustments related primarily to our BeiGene, Ltd. equity fair value adjustment.

(h)		The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and six months ended June 30, 2024, was 17.7% and 15.7%, respectively, compared to 18.1% and 22.6% for the corresponding periods of the prior year.

(i)		The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings.

Amgen Inc.
Reconciliations of Cash Flows
(In millions)
(Unaudited)

	Three months ended June 30,		Six months ended June 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 2,459	$ 4,109	$ 3,148	$ 5,173
Net cash (used in) provided by investing activities	(217)	(211)	(434)	1,147
Net cash (used in) provided by financing activities	(2,649)	(1,210)	(4,357)	20,299
(Decrease) increase in cash and cash equivalents	(407)	2,688	(1,643)	26,619
Cash and cash equivalents at beginning of period	9,708	31,560	10,944	7,629
Cash and cash equivalents at end of period	$ 9,301	$ 34,248	$ 9,301	$ 34,248


	Three months ended June 30,		Six months ended June 30,
	2024	2023	2024	2023
Net cash provided by operating activities	$ 2,459	$ 4,109	$ 3,148	$ 5,173
Capital expenditures	(238)	(271)	(468)	(615)
Free cash flow	$ 2,221	$ 3,838	$ 2,680	$ 4,558

Amgen Inc.
Reconciliation of GAAP EPS Guidance to Non-GAAP
EPS Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP diluted EPS guidance	$ 6.57	—	$ 7.62
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	11.09	—	11.14
Net losses from equity investments		1.33
Other		0.06
Non-GAAP diluted EPS guidance	$ 19.10	—	$ 20.10

Reconciliation of GAAP Tax Rate Guidance to Non-GAAP
Tax Rate Guidance for the Year Ending December 31, 2024
(Unaudited)

GAAP tax rate guidance	6.0 %	—	7.5 %
Tax rate of known adjustments discussed above	8.5 %	—	9.0 %
Non-GAAP tax rate guidance	15.0 %	—	16.0 %

RAD Increases Ownership in Radiopharm Ventures to 75%

Radiopharm Theranostics Investor Kit

GET YOUR FREE INVESTOR KIT

Investor Insight

Overview

Company Highlights

Technology and Clinical Pipeline

Management Team

Paul Hopper – Executive Chairman

Riccardo Canevari – Managing Director and Chief Executive Officer

Dr. Sherin Al-Safadi - Vice-president, Medical Affairs

Vimal Patel - Vice-president, CMC

Description

Highlights of the report:

What are radiopharmaceuticals?

Radiopharmaceuticals in diagnostics

Radiopharmaceutical innovation

Oncological applications

Potential opportunities

Investor takeaway

1. ProShares Ultra NASDAQ Biotechnology (NASDAQ:BIB)

2. Global X Genomics & Biotechnology ETF (NASDAQ:GNOM)

3. Tema Obesity and Cardiometabolic ETF (NASDAQ:HRTS)

4. Tema Oncology ETF (NASDAQ:CANC)

5. Virtus LifeSci Biotech Products ETF (ARCA:BBP)

1. Medicenna (TSX:MDNA)

2. ME Therapeutics Holdings (CSE:METX)

3. Cardiol Therapeutics (TSX:CRDL)

Company Highlights

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