Waiver of ASX Listing Rule 10.1 Granted

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (Hydralyte North America or the Company) refers to its announcement dated 27 March 2024 (“27 March 2024 Announcement”) where the Company advised that it had signed a variation to its facility agreement with boutique asset manager and existing substantial shareholder PURE Asset Management Pty Ltd as trustee for The Income and Growth Fund (“PURE” or “PURE Asset Management”) (“Original PURE Facility”).

All capitalised terms in this announcement have the same meaning as defined in the 27 March 2024 Announcement.

Under the terms of the variation (“Amended PURE Facility”), Hydralyte secured A$1.7m in new funding and two additional tranches, valued at A$1.5m each, which can be accessed at the discretion of PURE. A condition precedent to the Amended PURE Facility becoming effective (and thus access to the additional funding under the Amended PURE Facility becoming available), was the requirement of a waiver of Listing Rule 10.1 in order to vary the Original PURE Facility.

Hydralyte is pleased to advise that on 24 April 2024 ASX granted a waiver of Listing Rule 10.1 to allow the Company to amend the Original PURE Facility without shareholder approval in accordance with the terms of the Amended PURE Facility, and to secure its obligations under the Amended PURE Facility.

Click here for the full ASX Release

This article includes content from The Hydration Pharmaceuticals Company Limited, 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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AMGEN ANNOUNCES WEBCAST OF 2024 FIRST QUARTER FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced that it will report its first quarter 2024 financial results on Thursday, May 2, 2024 after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET . Participating in the call from Amgen will be Robert A. Bradway chairman and chief executive officer, and other members of Amgen's senior management team.

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

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$Millions, except percentages	Q1 '24			Q1 '23	YOY Δ
	US	ROW	TOTAL	TOTAL	TOTAL
Repatha ^®	$ 273	$ 244	$ 517	$ 388	33 %
Prolia ^®	657	342	999	927	8 %
EVENITY ^®	236	106	342	254	35 %
BLINCYTO ^®	153	91	244	194	26 %
Vectibix ^®	120	127	247	233	6 %
KYPROLIS ^®	234	142	376	358	5 %
LUMAKRAS ^® /LUMYKRAS ^™	53	29	82	74	11 %
XGEVA ^®	366	195	561	536	5 %
Nplate ^®	190	127	317	362	(12 %)
MVASI ^®	105	97	202	202	— %
TEZSPIRE ^®	173	—	173	96	80 %
Otezla ^®	293	101	394	392	1 %
Enbrel ^®	561	6	567	579	(2 %)
AMJEVITA ^® /AMGEVITA ^™	30	138	168	164	2 %
TEPEZZA ^® **	419	5	424	—	N/A
KRYSTEXXA ^® **	235	—	235	—	N/A
UPLIZNA ^® **	70	10	80	—	N/A
TAVNEOS ^®	45	6	51	23	*
Ultra rare products**	166	3	169	—	N/A
EPOGEN ^®	41	—	41	60	(32 %)
Aranesp ^®	100	249	349	355	(2 %)
Parsabiv ^®	65	40	105	91	15 %
Neulasta ^®	87	31	118	249	(53 %)
Other products***	301	56	357	309	16 %
Total product sales	$ 4,973	$ 2,145	$ 7,118	$ 5,846	22 %

*Change in excess of 100%
**Horizon-acquired products, and the Ultra rare products consist of RAVICTI ^® , PROCYSBI ^® , ACTIMMUNE ^® , BUPHENYL ^® , and QUINSAIR ^®
***Consists of (i) KANJINTI ^® , Aimovig ^® , RIABNI ^® , Corlanor ^® , NEUPOGEN ^® , AVSOLA ^® , IMLYGIC ^® , Sensipar ^® /Mimpara ^™ , BEKEMV ^™ , and WEZLANA ^™ /WEZENLA ^™ , where Biosimilars total $176 million in Q1 '24 and $121 million in Q1 '23; and (ii) Horizon-acquired products including RAYOS ^® , PENNSAID ^® , and DUEXIS ^®
N/A = not applicable

$Millions, except percentages	GAAP			Non-GAAP
	Q1 '24	Q1 '23	YOY Δ	Q1 '24	Q1 '23	YOY Δ
Cost of Sales	$ 3,200	$ 1,720	86 %	$ 1,340	$ 1,016	32 %
% of product sales	45.0 %	29.4 %	15.6 pts	18.8 %	17.4 %	1.4 pts
Research & Development	$ 1,343	$ 1,058	27 %	$ 1,317	$ 1,044	26 %
% of product sales	18.9 %	18.1 %	0.8 pts	18.5 %	17.9 %	0.6 pts
Selling, General & Administrative	$ 1,808	$ 1,258	44 %	$ 1,712	$ 1,224	40 %
% of product sales	25.4 %	21.5 %	3.9 pts	24.1 %	20.9 %	3.2 pts
Other	$ 105	$ 148	(29 %)	$ —	$ —	N/A
Total Operating Expenses	$ 6,456	$ 4,184	54 %	$ 4,369	$ 3,284	33 %

Operating Margin
operating income as % of product sales	13.9 %	32.9 %	(19.0) pts	43.2 %	48.3 %	(5.1) pts

Tax Rate	(66.2) %	17.5 %	(83.7) pts	15.4 %	17.8 %	(2.4) pts

pts: percentage points
N/A = not applicable

$Billions, except shares	Q1 '24	Q1 '23	YOY Δ
Operating Cash Flow	$ 0.7	$ 1.1	$ (0.4)
Capital Expenditures	$ 0.2	$ 0.3	$ (0.1)
Free Cash Flow	$ 0.5	$ 0.7	$ (0.3)
Dividends Paid	$ 1.2	$ 1.1	$ 0.1
Share Repurchases	$ —	$ —	$ —
Average Diluted Shares (millions)	536	538	(2)

Note: Numbers may not add due to rounding

$Billions	3/31/24	12/31/23	YTD Δ
Cash and Investments	$ 9.7	$ 10.9	$ (1.2)
Debt Outstanding	$ 64.0	$ 64.6	$ (0.6)

Note: Numbers may not add due to rounding

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

	Three months ended March 31,
	2024	2023
Revenues:
Product sales	$ 7,118	$ 5,846
Other revenues	329	259
Total revenues	7,447	6,105

Operating expenses:
Cost of sales	3,200	1,720
Research and development	1,343	1,058
Selling, general and administrative	1,808	1,258
Other	105	148
Total operating expenses	6,456	4,184

Operating income	991	1,921

Other income (expense):
Interest expense, net	(824)	(543)
Other (expense) income, net	(235)	2,064

(Loss) income before income taxes	(68)	3,442

Provision for income taxes	45	601

Net (loss) income	$ (113)	$ 2,841

(Loss) earnings per share:
Basic	$ (0.21)	$ 5.32
Diluted	$ (0.21)	$ 5.28

Weighted-average shares used in calculation of (loss) earnings per share:
Basic	536	534
Diluted	536	538

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

	March 31,	December 31,
	2024	2023
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$ 9,708	$ 10,944
Trade receivables, net	6,776	7,268
Inventories	8,724	9,518
Other current assets	2,821	2,602
Total current assets	28,029	30,332

Property, plant and equipment, net	6,002	5,941
Intangible assets, net	31,372	32,641
Goodwill	18,570	18,629
Other noncurrent assets	9,007	9,611
Total assets	$ 92,980	$ 97,154

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities	$ 15,755	$ 16,949
Current portion of long-term debt	3,959	1,443
Total current liabilities	19,714	18,392

Long-term debt	60,061	63,170
Long-term deferred tax liabilities	1,862	2,354
Long-term tax liabilities	3,964	4,680
Other noncurrent liabilities	2,357	2,326
Total stockholders' equity	5,022	6,232
Total liabilities and stockholders' equity	$ 92,980	$ 97,154

Shares outstanding	536	535

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

	Three months ended March 31,
	2024	2023
GAAP cost of sales	$ 3,200	$ 1,720
Adjustments to cost of sales:
Acquisition-related expenses (a)	(1,860)	(669)
Certain net charges pursuant to our restructuring and cost savings initiatives	—	(35)
Total adjustments to cost of sales	(1,860)	(704)
Non-GAAP cost of sales	$ 1,340	$ 1,016

GAAP cost of sales as a percentage of product sales	45.0 %	29.4 %
Acquisition-related expenses (a)	(26.2)	(11.4)
Certain net charges pursuant to our restructuring and cost savings initiatives	0.0	(0.6)
Non-GAAP cost of sales as a percentage of product sales	18.8 %	17.4 %

GAAP research and development expenses	$ 1,343	$ 1,058
Adjustments to research and development expenses:
Acquisition-related expenses (b)	(26)	(14)
Non-GAAP research and development expenses	$ 1,317	$ 1,044

GAAP research and development expenses as a percentage of product sales	18.9 %	18.1 %
Acquisition-related expenses (b)	(0.4)	(0.2)
Non-GAAP research and development expenses as a percentage of product sales	18.5 %	17.9 %

GAAP selling, general and administrative expenses	$ 1,808	$ 1,258
Adjustments to selling, general and administrative expenses:
Acquisition-related expenses (b)	(96)	(34)
Non-GAAP selling, general and administrative expenses	$ 1,712	$ 1,224

GAAP selling, general and administrative expenses as a percentage of product sales	25.4 %	21.5 %
Acquisition-related expenses (b)	(1.3)	(0.6)
Non-GAAP selling, general and administrative expenses as a percentage of product sales	24.1 %	20.9 %

GAAP operating expenses	$ 6,456	$ 4,184
Adjustments to operating expenses:
Adjustments to cost of sales	(1,860)	(704)
Adjustments to research and development expenses	(26)	(14)
Adjustments to selling, general and administrative expenses	(96)	(34)
Certain net charges pursuant to our restructuring and cost savings initiatives (c)	1	(141)
Certain other expenses (d)	(106)	(7)
Total adjustments to operating expenses	(2,087)	(900)
Non-GAAP operating expenses	$ 4,369	$ 3,284


	Three months ended March 31,
	2024	2023
GAAP operating income	$ 991	$ 1,921
Adjustments to operating expenses	2,087	900
Non-GAAP operating income	$ 3,078	$ 2,821

GAAP operating income as a percentage of product sales	13.9 %	32.9 %
Adjustments to cost of sales	26.2	12.0
Adjustments to research and development expenses	0.4	0.2
Adjustments to selling, general and administrative expenses	1.3	0.6
Certain net charges pursuant to our restructuring and cost savings initiatives (c)	0.0	2.5
Certain other expenses (d)	1.4	0.1
Non-GAAP operating income as a percentage of product sales	43.2 %	48.3 %

GAAP interest expense, net	$ (824)	$ (543)
Adjustments to interest expense, net:
Interest expense on acquisition-related debt (e)	—	123
Non-GAAP interest expense, net	$ (824)	$ (420)

GAAP other (expense) income, net	$ (235)	$ 2,064
Adjustments to other (expense) income, net
Interest income and other expenses on acquisition-related debt (e)	—	(6)
Net losses (gains) from equity investments (f)	510	(1,853)
Total adjustments to other (expense) income, net	510	(1,859)
Non-GAAP other income, net	$ 275	$ 205

GAAP (loss) income before income taxes	$ (68)	$ 3,442
Adjustments to (loss) income before income taxes:
Adjustments to operating expenses	2,087	900
Adjustments to interest expense, net	—	123
Adjustments to other (expense) income, net	510	(1,859)
Total adjustments to (loss) income before income taxes	2,597	(836)
Non-GAAP income before income taxes	$ 2,529	$ 2,606

GAAP provision for income taxes	$ 45	$ 601
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (g)	359	(117)
Other income tax adjustments (h)	(15)	(19)
Total adjustments to provision for income taxes	344	(136)
Non-GAAP provision for income taxes	$ 389	$ 465

GAAP tax as a percentage of income before taxes	(66.2) %	17.5 %
Adjustments to provision for income taxes:
Income tax effect of the above adjustments (g)	82.2	1.0
Other income tax adjustments (h)	(0.6)	(0.7)
Total adjustments to provision for income taxes	81.6	0.3
Non-GAAP tax as a percentage of income before taxes	15.4 %	17.8 %

GAAP net (loss) income	$ (113)	$ 2,841
Adjustments to net (loss) income:
Adjustments to (loss) income before income taxes, net of the income tax effect	2,238	(719)
Other income tax adjustments (h)	15	19
Total adjustments to net (loss) income	2,253	(700)
Non-GAAP net income	$ 2,140	$ 2,141

Note: Numbers may not add due to rounding

Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited)

The following table presents the computations for GAAP and non-GAAP diluted earnings per share:

	Three months ended March 31, 2024		Three months ended March 31, 2023
	GAAP	Non-GAAP	GAAP	Non-GAAP
Net (loss) income	$ (113)	$ 2,140	$ 2,841	$ 2,141

Shares (Denominator):
Weighted-average shares for basic (loss) earnings per share	536	536	534	534
Effect of dilutive securities (i)	—	5	4	4
Weighted-average shares for diluted (loss) earnings per share (i)	536	541	538	538

Diluted (loss) earnings per share	$ (0.21)	$ 3.96	$ 5.28	$ 3.98


(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 months ended March 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended March 31, 2023, the adjustments related primarily to noncash amortization of intangible assets from business acquisitions.

(c)		For the three months ended March 31, 2023, the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023.

(d)		For the three months ended March 31, 2024, the adjustments related primarily to a net impairment charge for an in-process R&D asset and changes in contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three months ended March 31, 2023, the adjustments related to changes in contingent consideration liabilities.

(e)		For the three months ended March 31, 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.

(f)		For the three months ended March 31, 2024 and 2023, the adjustments related primarily to our BeiGene, Ltd. equity fair value adjustment.

(g)		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, this results in a tax impact at the U.S. marginal tax rate for certain adjustments, including the majority of amortization of intangible assets and certain gains and losses on our investments in equity securities, whereas the tax impact of other adjustments, including the amortization of acquired inventory 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 months ended March 31, 2024, was 13.8% compared to 14.0% for the corresponding period of the prior year.

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

(i)		During periods of net loss, diluted loss per share is equal to basic loss per share as the anti-dilutive effect of potential common shares is disregarded.

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

	Three months ended March 31,
	2024	2023
Net cash provided by operating activities	$ 689	$ 1,064
Net cash (used in) provided by investing activities	(217)	1,358
Net cash (used in) provided by financing activities	(1,708)	21,509
(Decrease) increase in cash and cash equivalents	(1,236)	23,931
Cash and cash equivalents at beginning of period	10,944	7,629
Cash and cash equivalents at end of period	$ 9,708	$ 31,560


	Three months ended March 31,
	2024	2023
Net cash provided by operating activities	$ 689	$ 1,064
Capital expenditures	(230)	(344)
Free cash flow	$ 459	$ 720

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

GAAP diluted EPS guidance	$ 7.15	—	$ 8.40
*Known adjustments to arrive at non-GAAP:**
Acquisition-related expenses (a)	10.98	—	11.03
Net losses from equity investments		0.74
Other		0.08
Non-GAAP diluted EPS guidance	$ 19.00	—	$ 20.20

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

GAAP tax rate guidance	9.5 %	—	11.0 %
Tax rate of known adjustments discussed above	5.0 %	—	5.5 %
Non-GAAP tax rate guidance	15.0 %	—	16.0 %

Waiver of ASX Listing Rule 10.1 Granted

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Hydralyte Rapid Rehydration

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Oliver Baker – CEO

George Livery – Chairman

Adem Karafili – Non-executive Director

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Margaret Hardin – Non-executive Director

Brandon Fishman – US Advisor

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