On April 2022 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2022 (Presentation, Ipsen, APR 27, 2022, View Source [SID1234613078]).
Highlights
− A strong first-quarter total-sales performance, with growth of 9.6% at CER1
(12.5% as reported) to
€687.9m, driven by Decapeptyl (triptorelin), Dysport (botulinum toxin type A), Cabometyx
(cabozantinib) and Onivyde (irinotecan liposome injection) double-digit growth and flat sales of
Somatuline (lanreotide)
− Confirmation of full-year guidance for 2022, with total-sales growth greater than 2.0% at CER1 and a core
operating margin greater than 35.0% of total sales
− Transaction announced in February 2022 for the divestment of the Consumer HealthCare (CHC) business
anticipated to be completed by end of Q3 2022
Q1 2022 total sales
Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only,
in accordance with IFRS 5.
First Quarter
2022 2021 % change
€m €m Actual CER1
Oncology 556.4 495.4 12.3% 8.9%
Neuroscience 120.2 103.1 16.6% 15.7%
Rare Disease 11.3 13.1 -13.4% -15.0%
Total 687.9 611.5 12.5% 9.6%
David Loew, Chief Executive Officer, commented:
"The execution of our strategy was reflected in our first-quarter performance across the business. The strong
sales were in line with our expectations, with Decapeptyl, Dysport, Cabometyx and Onivyde all delivering
double-digit growth. Our guidance for the year, which assumes increasing levels of competition for Somatuline,
is underpinned by our strong platform of growth across these core and innovative medicines.
Alongside the anticipated U.S. regulatory resubmission for palovarotene in the first half of the year, we look
forward to a number of important data readouts in the second half, while our pipeline will continue to be
replenished through the external-innovation strategy. It is an exciting time for Ipsen as we deliver on our
strategy, produce strong results, expand our pipeline and focus together, for patients and society."
1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period
by applying the exchange rates used for the prior period.
2
Full-year 2022 guidance
Ipsen today confirms its financial guidance for FY 2022, which excludes any contribution from CHC:
− Total-sales growth greater than 2.0%, at CER2
. Based on the level of exchange rates in Q1 2022, Ipsen
anticipates an additional favorable impact of 2% from currencies in the year
− Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental
investments from future external-innovation transactions
This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other
countries in the E.U., as well as increased competition in the U.S.
Ongoing conflict in Ukraine
Ipsen is firmly committed to the safety and care of its employees and to providing essential support and access
to its treatments and medicines for patients.
Since the beginning of the conflict in Ukraine, Ipsen’s immediate actions have been to ensure that all
colleagues are safe and to limit any impact on the supply of medicines. The Company has also provided
humanitarian relief via a donation of €1.5m in favor of two highly reputed humanitarian organizations: Tulipe,
a pharmaceutical distributor managing donations from health companies to meet the emergency needs of
populations in distress, and The Red Cross.
Ipsen’s position is to continue to serve patients with their healthcare needs, regardless of their country origin
and in compliance with applicable laws. In Russia, the Company has, however, suspended several promotional
activities, including advertising. No new clinical trials will be initiated in Russia.
In 2021, Ipsen’s Specialty Care sales in Russia and Ukraine were less than 3.0% of total Specialty Care sales.
Consumer HealthCare
In February 2022, Ipsen announced that it had entered into exclusive negotiations with Mayoly Spindler for the
divestment of its global CHC business, a major step forward in the Company’s execution of its strategic
roadmap towards building a more-focused Ipsen, centering on Specialty Care. Ipsen confirms that the
transaction is anticipated to close by the end of Q3 2022, subject to regulatory approvals and customary closing
conditions.
Conference call
A conference call and webcast for investors and analysts will begin at 2pm Paris time today. Participants should
dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can
be accessed here. The event ID is 9681287.
Calendar
The Company intends to publish its H1 2022 results on 28 July 2022.
Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the threemonth period to 31 March 2022 (the quarter or Q1 2022), compared to the three-month period to 31 March
2021 (Q1 2021).
2 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
3
Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology,
Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in
over 100 countries. Alongside its external-innovation strategy, the Company’s research and development
efforts are focused on its innovative and differentiated technological platforms located in the heart of leading
biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China.
Ipsen, excluding its Consumer HealthCare business, has around 4,500 colleagues worldwide and is listed in
Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program
(ADR: IPSEY). For more information, visit ipsen.com.
Contacts
Investors
Craig Marks
Vice President, Investor Relations
+44 (0)7584 349 193
Adrien Dupin de Saint-Cyr
Investor Relations Manager
+33 6 64 26 17 49
Media
Mai Tran
Global Communications Director
+ 33 6 64 74 70 80
Ioana Piscociu
Senior Manager, Global Media Relations
+33 6 69 09 12 96
4
Sales by therapeutic area and medicine
Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only,
in accordance with IFRS 5.
A breakdown of medicine sales by geographical area is shown in the appendix.
First Quarter
2022 2021 % change
€m €m Actual CER3
Oncology 556.4 495.4 12.3% 8.9%
Somatuline 286.0 277.0 3.3% -0.7%
Decapeptyl 129.2 106.3 21.6% 19.0%
Cabometyx 98.9 83.3 18.8% 18.5%
Onivyde 40.1 26.5 51.4% 40.9%
Other Oncology 2.2 2.4 -8.5% -9.2%
Neuroscience 120.2 103.1 16.6% 15.7%
Dysport 118.4 101.8 16.3% 15.2%
Other Neuroscience 1.7 1.3 34.4% 49.8%
Rare Disease 11.3 13.1 -13.4% -15.0%
NutropinAq 7.1 8.5 -15.8% -16.1%
Increlex 4.2 4.6 -9.0% -13.0%
Total Sales 687.9 611.5 12.5% 9.6%
Oncology
Oncology sales of €556.4m represented growth of 8.9%3 and comprised 80.9% of total sales in the quarter
(Q1 2021: 81.0%).
a) Somatuline sales declined by 0.7%3
to €286.0m. In North America, sales fell by 6.9%3
, with
encouraging volume growth supported by continued market-share gains more than offset by adverse
pricing, primarily a result of unfavorable movements in channel mix, as well as changes in wholesalerbuying patterns. In Europe, effects from the launch of generic lanreotide in some European markets
reduced sales growth to 0.4%3
, while sales in the Rest of the World grew by 39.3%3
.
b) Decapeptyl sales of €129.2m represented growth of 19.0%3
, mainly driven by market growth and
inventory in China, along with continued market-share gains in Europe, primarily in France and Italy.
c) Cabometyx sales reached €98.9m, up by 18.5%3
, driven by a strong volume uptake across most
geographies, mainly in the renal cell carcinoma indication.
d) Onivyde sales of €40.1m, growing by 40.9%3
, were primarily driven by sales to Ipsen’s ex-U.S.
partner, as well as market-share gains and volume growth in the U.S.
3 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
5
Neuroscience
Neuroscience sales increased by 15.7%4
to €120.2m and comprised 17.5% of total sales in the quarter
(Q1 2021: 16.9%).
Dysport sales reached €118.4m, up by 15.2%4
, driven by a continued strong performance in most aesthetics
markets, including those operated by Ipsen’s partner, Galderma, as well as therapeutics markets in Europe,
North America and the Middle East.
Rare Disease
Rare Disease sales declined by 15.0%4
to €11.3m and comprised 1.6% of total sales in the quarter (Q1 2021:
2.1%).
NutropinAq (somatropin) sales of €7.1m, a decline of 16.1%4
, reflected competitive pressures across Europe.
Increlex (mecasermin) sales of €4.2m, a decrease of 13.0%4
, were impacted by lower demand in the U.S.
Sales by geographical area
A breakdown of medicine sales by geographical area is shown in the appendix.
First Quarter
2022 2021 % change
€m €m Actual CER4
North America 226.4 207.0 9.4% 1.8%
Europe5 304.7 288.8 5.5% 4.8%
Rest of the World 156.9 115.7 35.5% 35.4%
Total Sales 687.9 611.5 12.5% 9.6%
North America
Sales of €226.4m in the quarter reflected growth of 1.8%4
, driven by strong performances from Dysport and
Onivyde, offset by the Somatuline sales decline of 6.9%4
.
North America sales comprised 32.9% of total sales in the quarter (Q1 2021: 33.8%).
Europe
Sales reached €304.7m in the quarter, an increase of 4.8%4
, mainly driven by Decapeptyl’s market-share
uptakes in major countries and Cabometyx, with solid performances in both France and Spain. Effects from
the launch of generic lanreotide in some European markets reduced Somatuline sales growth to 0.4%4
, while
Dysport sales were impacted by shipment phasing to Ipsen’s partner, Galderma.
Sales in Europe comprised 44.3% of total sales in the quarter (Q1 2021: 47.2%).
4 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
5
In this announcement, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland.
6
Rest of the World
Sales reached €156.9m in the quarter, an increase of 35.4%6
, driven by solid volumes growth in Oncology and
Neuroscience. Decapeptyl sales increased by 31.6%6
, reflecting volume uptakes in Asia, partly reflecting
inventory increases in China, while Cabometyx and Somatuline delivered further market-share gains across
several countries. Dysport sales were primarily driven by solid performances in aesthetics markets across all
geographies, as well as continued growth in therapeutics markets.
Rest of the World sales comprised 22.8% of total sales in the quarter (Q1 2021: 18.9%).
Consumer HealthCare
CHC sales of €54.7m, an increase of 14.8%6
, were driven by the growth of Smecta (diosmectite), reflecting
the COVID-19 recovery and the performance in Europe, China and Vietnam.
Total sales in this announcement exclude CHC sales, in accordance with IFRS 5.
6 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange
rates used for the prior period.
7
Forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management
strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties
that may cause actual results, performance or events to differ materially from those anticipated herein. All of
the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’,
‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements,
including Ipsen’s expectations regarding future events, including regulatory filings and determinations.
Moreover, the targets described in this document were prepared without taking into account external growth
assumptions and potential future acquisitions, which may alter these parameters. These objectives are based
on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely
to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these
targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in
early development phase or clinical trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition
from generic medicine that might translate into a loss of market share. Furthermore, the research and
development process involves several stages each of which involves the substantial risk that Ipsen may fail to
achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested
significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will
be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to
demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine
will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful.
If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are
not limited to, general industry conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare
legislation; global trends toward healthcare cost containment; technological advances, new medicine and
patents attained by competitors; challenges inherent in new-medicine development, including obtaining
regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of
Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent
litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its
medicines which could potentially generate substantial royalties; these partners could behave in such ways
which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners
will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of
Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact
on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking
to update or revise any forward-looking statements, targets or estimates contained in this press release to
reflect any change in events, conditions, assumptions or circumstances on which any such statements are
based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set
out are not exhaustive and the reader is advised to refer to Ipsen’s 2021 Universal Registration Document,
available on ipsen.com.
8
Appendix: geographic breakdown of total sales by medicine
First Quarter
Total North America Europe7 Rest of the World
2022 2021 % change 2022 2021 % change 2022 2021 % change 2022 2021 % change
€m €m Actual CER8 €m €m Actual CER8 €m €m Actual CER8 €m €m Actual CER8
Oncology 556.4 495.4 12.3% 8.9% 184.3 176.2 4.6% -2.7% 267.9 247.1 8.4% 7.6% 104.3 72.1 44.6% 42.1%
Somatuline 286.0 277.0 3.3% -0.7% 151.5 151.5 0.0% -6.9% 105.5 104.4 1.1% 0.4% 29.0 21.1 37.3% 39.3%
Decapeptyl 129.2 106.3 21.6% 19.0% – – – – 73.7 66.0 11.7% 11.3% 55.5 40.3 37.9% 31.6%
Cabometyx 98.9 83.3 18.8% 18.5% 4.0 3.3 19.0% 10.7% 75.2 69.2 8.8% 8.3% 19.7 10.8 82.7% 85.9%
Onivyde 40.1 26.5 51.4% 40.9% 28.7 21.2 35.0% 25.6% 11.4 5.3 117.4% 103.0% – – – –
Other Oncology 2.2 2.4 -8.5% -9.2% 0.1 0.2 -39.7% -43.9% 2.0 2.3 -12.6% -12.9% 0.1 0.0 n.a. n.a.
Neuroscience 120.2 103.1 16.6% 15.7% 39.5 27.9 41.7% 32.5% 28.4 31.9 -11.0% -11.5% 52.3 43.3 20.8% 24.5%
Dysport 118.4 101.8 16.3% 15.2% 39.5 27.9 41.7% 32.5% 28.4 31.9 -11.0% -11.5% 50.5 42.0 20.4% 23.7%
Other Neuroscience 1.7 1.3 34.4% 49.8% – – – – – – – – 1.7 1.3 34.4% 49.8%
Rare Disease 11.3 13.1 -13.4% -15.0% 2.6 2.9 -10.1% -16.4% 8.4 9.8 -14.5% -14.7% 0.3 0.3 -11.4% -11.4%
NutropinAq 7.1 8.5 -15.8% -16.1% – – – – 6.8 8.2 -16.5% -16.8% 0.3 0.3 7.6% 7.2%
Increlex 4.2 4.6 -9.0% -13.0% 2.6 2.9 -10.1% -16.4% 1.5 1.6 -3.8% -4.0% 0.0 0.1 -67.1% -67.3%
Total Sales 687.9 611.5 12.5% 9.6% 226.4 207.0 9.4% 1.8% 304.7 288.8 5.5% 4.8% 156.9 115.7 35.5% 35.4%
7
In this announcement, Europe is defined as the E.U., the U.K., Iceland, Liechtenstein, Norway and Switzerland.
8 At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.

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On April 27, 2022 PTC (NASDAQ: PTC) reported financial results for its second fiscal quarter ended March 31, 2022 (Press release, PTC Therapeutics, APR 27, 2022, View Source [SID1234613077]).

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"In the second quarter we continued to see our key operating and financial metrics showing strong performance. We delivered organic constant currency ARR growth of 13% year over year to end Q2 at $1.56 billion. In Q2, our cash from operations was $142 million, up 17% year over year, and our adjusted free cash flow was $158 million, up 22% year over year. The strength in Q2 was broad-based across all segments and geographic regions, driven by demand for digital transformation and SaaS," said James Heppelmann, President and CEO, PTC.

"Our differentiated product portfolio and growing SaaS capabilities position PTC to drive superior value for customers. Our market position coupled with our subscription model, which took us years of hard work to put in place, is highly resilient and positions us to continue to deliver strong double-digit ARR growth. Based on our strong performance in the first half of the year and the momentum we have created, we are raising our fiscal 2022 guidance for ARR and free cash flow," concluded Heppelmann.

Second Quarter 2022 Highlights 1
Key operating and financial highlights are set forth below. For additional details, please refer to the Q2’22 earnings presentation and financial data tables that have been posted to the Investor Relations section of our website at investor.ptc.com. Revenue and, as a result, operating margin and earnings per share are impacted by revenue recognition under ASC 606.

ARR was $1,532 million at the end of Q2’22, up 11% compared to Q2’21. On a constant currency basis, ARR was $1,564 million, up 13% compared to Q2’21, and above guidance of $1,540 million to $1,550 million. ARR at the end of Q2’22 includes a $4 million reduction associated with discontinuing our business operations in Russia.
Cash flow from operations was $142 million, free cash flow was $140 million, and adjusted free cash flow was $158 million in Q2’22, compared to Q2’21 cash flow from operations of $122 million, free cash flow of $116 million, and adjusted free cash flow of $130 million.
Revenue was $505 million in Q2’22 compared to $462 million in Q2’21, representing growth of 9%. On a constant currency basis, year-over-year revenue growth in Q2’22 was 13%.
Operating margin was 32% in Q2’22, compared to 22% in Q2’21. Non-GAAP operating margin in Q2’22 was 42%, compared to 37% in Q2’21. GAAP and non-GAAP operating margin expanded year over year due to higher revenue and operational discipline.
Earnings per share was $0.76 in Q2’22, compared to $0.92 in Q2’21. Non-GAAP earnings per share in Q2’22 was $1.39, compared to $1.08 in Q2’21. GAAP EPS in Q2’22 was negatively impacted by a non-cash charge within other expense due to a decline in value of a publicly traded equity investment, which was sold in Q2’22.
Total cash and cash equivalents as of the end of Q2’22 was $307 million. Gross debt was $1.28 billion as of the end of Q2’22. During Q2’22, we repaid $175 million on our revolving credit facility and we had proceeds of $43 million from the sale of the aforementioned equity investment.
Stock repurchases were $5 million in Q2’22, reflecting the settlement of repurchases that were initiated in Q1’22
1 We include operating and non-GAAP financial measures in our operational highlights. The detailed definitions of these items and reconciliations of non-GAAP financial measures to comparable GAAP measures are included below and in the reconciliation tables at the end of this press release.

Fiscal 2022 and Q3’22 Guidance
"PTC delivered strong second quarter results that exceeded our expectations," said Kristian Talvitie, EVP and CFO, PTC. "Based on our Q2 performance and our forecast for the remainder of the year, we are raising our guidance for fiscal 2022 ARR, Free Cash Flow, and Revenue. Despite significant foreign exchange headwinds and the impact of exiting our business in Russia, our strong execution and operational discipline have helped us to deliver solid financial performance thus far in fiscal 2022, and we believe we are well positioned to deliver on our updated targets for the year."

(1)On a constant currency basis, using our FY’22 Plan foreign exchange rates (rates as of September 30, 2021) for all periods

(2)FY’22 cash from operations and free cash flow guidance include expected restructuring payments of $45 million (current estimate is $40 million to $45 million) and transaction-related payments of approximately $5 million (already incurred in 1H’22), both of which are excluded from FY’22 adjusted free cash flow guidance; Q3’22 cash from operations and free cash flow guidance include expected restructuring payments of approximately $10 million and transaction-related payments of approximately $5 million (already incurred in 1H’22), both of which are excluded from Q3’22 adjusted free cash flow guidance

(3)Free cash flow and adjusted free cash flow guidance are net of expected capex of approximately $25 million (previously $30 million) in FY’22 and $5 million in Q3’22

Our FY’22 and Q3’22 financial guidance includes the assumptions below:

We provide ARR guidance on a constant currency basis, using our FY’22 Plan foreign exchange rates (rates as of September 30, 2021) for all periods. Based on foreign exchange rate fluctuations as of the end of Q2’22, we currently expect a $34 million headwind (previously $13 million), relative to our constant currency ARR guidance for FY’22, and a $32 million headwind, relative to our constant currency ARR guidance for Q3’22.
We expect FY’22 organic churn to improve by approximately 100 basis points over FY’21.
Due to invoicing seasonality, the majority of our collections occur in the first half of our fiscal year. Q4 is our lowest cash flow generation quarter.
Costs are expected to ramp throughout FY’22 due to hiring and increased SaaS investments. At the mid-point of ARR guidance, we expect FY’22 GAAP operating expenses to increase approximately 3% to 4% (previously 4% to 5%) and non-GAAP operating expenses to increase approximately 2% to 3% over FY’21.
FY’22 GAAP results are expected to include the items outlined below, totalling $293 million to $308 million (previously $275 million to $280 million), as well as their related tax effects:
$160 million to $170 million of stock-based compensation expense (previously $178 million)
$58 million of intangible asset amortization expense
$35 million to $40 million of restructuring charges (previously $40 million to $45 million)
$35 million of FY’22 net realized losses from the sale of an equity investment (new)
Approximately $5 million of transaction-related charges (new)
Our FY’22 guidance does not reflect operating results of the Intland acquisition and the ITCI transaction, the impact of business combination accounting, incremental interest expense, or transaction-related charges not incurred as of the end of Q2’22.
Related to restructuring, for FY’22 we expect:
P&L charges of $35 million to $40 million (previously $40 million to $45 million), of which $32 million was incurred in the first half of FY’22.
Cash outflows for restructuring payments of $40 million to $45 million (previously $45 to $50 million), of which $28 million was paid in the first half of FY’22. We expect the majority of remaining payments to be made in Q3’22. Restructuring payments in FY’22 include $5 million related to prior period actions, primarily the relocation of our headquarters in FY’19.
Our FY’22 GAAP tax rate is expected to be approximately 20% and our non-GAAP tax rate is expected to be approximately 19%.
FY’22 capital expenditures are expected to be approximately $25 million (previously $30 million).
For the remainder of FY’22, we plan to focus on de-levering. In FY’23 and on a go-forward basis, assuming our Debt/EBITDA ratio is below 3x, our goal is to return approximately 50% of our free cash flow to shareholders via share repurchases.
PTC’s Fiscal Second Quarter Results Conference Call
The Company will host a conference call to discuss results at 5:00 pm ET on Wednesday, April 27, 2022. To participate in the live conference call, dial (888) 330-2508 or (240) 789-2735 and provide the passcode 7328695, or log in to the webcast, available on PTC’s Investor Relations website. A replay will also be available.

Important Disclosures
Important Information About Our Non-GAAP Financial Measures
PTC provides supplemental non-GAAP financial measures to its financial results. We use these non-GAAP financial measures, and we believe that they assist our investors, to make period-to-period comparisons of our operating performance because they provide a view of our operating results without items that are not, in our view, indicative of our operating results. These non-GAAP financial measures should not be construed as an alternative to GAAP results as the items excluded from the non-GAAP financial measures often have a material impact on our operating results, certain of those items are recurring, and others often recur. Management uses, and investors should consider, our non-GAAP financial measures only in conjunction with our GAAP results.

Non-GAAP operating expense, non-GAAP operating margin, non-GAAP gross profit, non-GAAP gross margin, non-GAAP net income and non-GAAP EPS exclude the effect of the following items: stock-based compensation; amortization of acquired intangible assets; acquisition-related and other transactional charges included in general and administrative expenses; restructuring and other charges, net; certain non-operating charges and credits; and income tax adjustments. Additional information about the items we exclude from our non-GAAP financial measures and the reasons we exclude them can be found in "Non-GAAP Financial Measures" on page 24 of our Annual Report on Form 10-K for the fiscal year ended September 30, 2021. In FY’21, we incurred tax expense related to a South Korean tax matter which is excluded from our non-GAAP financial measures as it is related to prior periods and not included in management’s view of results for comparative purposes. We also recorded a tax benefit in FY’21 related to the release of our U.S. valuation allowance as a result of the Arena acquisition and our conclusion that it is now more likely than not that we will realize the majority of our deferred tax assets in the U.S. As the non-GAAP tax provision is calculated assuming that there is no valuation allowance, this benefit has been excluded from our non-GAAP financial measures.

Free Cash Flow and Adjusted Free Cash Flow – PTC provides information on free cash flow and adjusted free cash flow to enable investors to assess our ability to generate cash without incurring additional external financings and to evaluate our performance against our announced long-term goals and intent to return approximately 50% of our free cash flow to shareholders via stock repurchases. Free cash flow is cash provided by (used in) operations net of capital expenditures. Adjusted free cash flow is free cash flow net of restructuring payments, acquisition-related payments, and non-ordinary course tax-related payments or receipts. Free cash flow and adjusted free cash flow are not measures of cash available for discretionary expenditures.

Constant Currency (CC) Change Metric – We present CC information to provide a framework for assessing how our underlying business performed excluding the effects of foreign currency rate fluctuations. To present CC information, FY’22 and comparative prior period results for entities reporting in currencies other than United States dollars are converted into United States dollars using the foreign exchange rate as of September 30, 2021, rather than the actual exchange rates in effect during that period.

Operating Measures
ARR – To help investors understand and assess the performance of our business as a SaaS and on-premise subscription company we provide an ARR (Annual Run Rate) operating measure. ARR represents the annualized value of our portfolio of active subscription software, cloud, SaaS, and support contracts as of the end of the reporting period. ARR includes orders placed under our Strategic Alliance Agreement with Rockwell Automation, including orders placed to satisfy contractual minimum commitments.

We believe ARR is a valuable operating metric to measure the health of a subscription business because it captures expected subscription and support cash generation from customers.

On April 27, 2022 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company reported the presentation of new clinical research showcasing the potential of its investigational KRASG12C inhibitor, adagrasib, in a study of patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3 to 7, 2022 in Chicago, IL (Press release, Mirati, APR 27, 2022, View Source [SID1234613076]).

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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

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"Mirati continues to develop adagrasib with the goal of having a meaningful impact on patients with lung cancer," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Our data at this year’s ASCO (Free ASCO Whitepaper) congress includes important insights into adagrasib’s clinical profile in patients with NSCLC who harbor a KRASG12C mutation, including those with active and untreated CNS metastases, which is a serious and potentially fatal complication for these patients. We believe adagrasib has the potential to transform the lives of those with KRAS-mutated cancers including lung, colorectal, pancreatic and other tumors that carry the KRASG12C mutation."

The adagrasib New Drug Application (NDA) is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. The application is being reviewed under the FDA Real Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

Mirati presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Presentation Title: KRYSTAL-1: Activity and Safety of Adagrasib (MRTX849) in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring a KRASG12C Mutation
Author: Alexander I. Spira
Abstract Number: 9002
Session: Lung Cancer—Non-Small Cell Metastatic
Presentation Date/Time: Friday, June 3, 2022 at 2:24 to 2:36 PM ET/1:24 to 1:36 PM CT

Presentation Title: Activity of Adagrasib (MRTX849) in Patients with KRASG12C-Mutated NSCLC and Active, Untreated CNS Metastases in the KRYSTAL-1 Trial
Author: Joshua K Sabari
Abstract Number: LBA9009
Session: Clinical Science Symposium/Including the Excluded: Advancing Care for All Patients With Lung Cancer
Presentation Date/Time: June 6, 2022 at 5:30 to 5:42 PM ET/4:30 to 4:42 PM CT

Mirati will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 2097.

Virtual Investor Event

Mirati Therapeutics will host an Investor Event on Monday, June 6, 2022 at 8:00 PM ET / 7:00 PM CT.

Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

On April 27, 2022 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that updated results from seven studies involving the company’s five novel drug candidates will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Ascentage Pharma, APR 27, 2022, View Source;ascentage-pharma-to-present-data-from-seven-clinical-studies-at-the-2022-american-society-of-clinical-oncology-annual-meeting-301534837.html [SID1234613075]). The company will present clinical trials involving the third-generation tyrosine kinase inhibitor (TKI) olverembatinib (HQP1351); as well as the following investigational agents: (1) Bcl-2 inhibitor lisaftoclax (APG-2575); (2) MDM-p53 inhibitor alrizomadlin (APG-115); (3) ALK inhibitor APG-2449; and (4) dual Bcl-2/Bcl-xL inhibitor pelcitoclax (APG-1252).

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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

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The ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community. This year’s ASCO (Free ASCO Whitepaper) Annual Meeting will take place both online and in-person (McCormick Place; Chicago, IL) on June 3–7, 2022.

"This is the fifth consecutive year in which Ascentage-sponsored clinical results have been selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting," said Dr. Yifan Zhai, Chief Medical Officer. "We are pleased to be offered a further opportunity to showcase our company’s progress on multiple clinical trials and demonstrate our ample capabilities in global innovation and R&D," she said.

"In addition to the updated results on lisaftoclax and alrizomadlin, two key drug candidates in our apoptosis-targeted pipeline, we will also release the first-in-human data of APG-2449, a promising drug candidate with potential as the first China-developed third-generation ALK inhibitor," according to Dr. Zhai.

"We also look forward to disseminating new clinical data on recently approved third-generation TKI olverembatinib in patients with gastrointestinal stromal tumor (GIST)," Dr. Zhai added. "We look forward to sharing these detailed results during the meeting. Moving forward, we will continue to accelerate these and other global clinical development programs, in an effort to expeditiously bring more therapeutic alternatives to patients as soon as possible."

These seven clinical studies to be presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Olverembatinib (HQP1351):

Promising antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor- (TKI-) resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST).

Format: Poster Discussion
Lisaftoclax (APG-2575):

A phase Ib/II study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL).

Format: Poster Presentation
Phase Ib/II study of BCL-2 inhibitor lisaftoclax (APG-2575) safety and tolerability when administered alone or combined with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor in patients with estrogen receptor-positive (ER⁺) breast cancer or advanced solid tumors.

Format: Poster Presentation
APG-115:

Alrizomadlin (APG-115):

Newly updated activity results of alrizomadlin (APG-115), a novel MDM2/p53 inhibitor, plus pembrolizumab: Phase 2 study in adults and children with various solid tumors.

Format: Poster Discussion
APG-2449:

First-in-human phase I results of APG-2449, a novel FAK and third-generation ALK/ ROS1 tyrosine kinase inhibitor (TKI), in patients (pts) with second-generation TKI-resistant ALK/ROS1 non-small-cell lung cancer (NSCLC) or mesothelioma.

Format: Poster Presentation
APG-1252:

Pelcitoclax (APG-1252):

Updated study results of pelcitoclax (APG-1252) in combination with osimertinib in patients (pts) with EGFR-mutant non-small-cell lung cancer (NSCLC).

Format: Poster Presentation
First-in-human study of pelcitoclax (APG-1252) in combination with paclitaxel in patients (pts) with relapsed/refractory small-cell lung cancer (R/R SCLC).

Format: Online Publication

On April 27, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported presentations from the Company’s global clinical development programs in hematologic malignancies and solid tumors at the 2022 Annual Meeting of the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) being held on June 3-7, 2022 (Press release, BeiGene, APR 27, 2022, View Source [SID1234613074]).

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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

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"We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

"We have more than 800 oncology researchers at BeiGene, and these data presentations highlight our important work to deliver potential new therapies to patients worldwide," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We are pleased to have a robust presence at this year’s ASCO (Free ASCO Whitepaper) and very much look forward to meeting with fellow cancer researchers in person."

BeiGene presentation highlights:

ASPEN: Long-term follow-up results of a Phase 3 randomized trial of zanubrutinib versus ibrutinib in patients with Waldenström macroglobulinemia.
ROSEWOOD: Zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma: primary analysis of the Phase 2 randomized ROSEWOOD trial.
RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer.
BeiGene Poster and Oral Presentations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title and Number

Session

Date and Time
(all times CDT)

Presenting Author

Hematologic Malignancies Clinical Data

Zanubrutinib plus obinutuzumab (Z-O) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): primary analysis of the phase 2 randomized ROSEWOOD trial

Abstract Number: 7510

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM
and
3:00 PM – 4:30 PM

Pier L. Zinzani, M.D., Ph.D.

ASPEN: Long-term follow-up results of a phase 3 randomized trial of zanubrutinib (ZANU) vs ibrutinib (IBR) in patients with Waldenström macroglobulinemia (WM)

Abstract Number: 7521

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4

3:00 PM – 4:30 PM
and

8:00 AM – 11:00 AM

Constantine S. Tam, M.D.

Tislelizumab, a PD-1 inhibitor for relapsed/refractory mature T/NK-cell neoplasms: results from a phase 2 study

Abstract Number: 7552

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Saturday, June 4
8:00 AM – 11:00 AM

Emmanuel Bachy. M.D., Ph.D.

Solid Tumor Clinical Data

RATIONALE 309: Updated progression-free survival (PFS), PFS after next line of treatment, and overall survival from a Phase 3 double-blind trial of tislelizumab versus placebo, plus chemotherapy, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Abstract Number: 384950

Plenary Session

Sunday, June 5
1:00 PM – 4:00 PM

Li Zhang, M.D.

Clinical outcomes associated with tislelizumab in patients (pts) with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (SOR) or lenvatinib (LEN) in RATIONALE-208.

Abstract Number: 4072

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Julien Edeline, M.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line (1L) therapy for patients (pts) with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study.

Abstract Number: 1031

Poster session – Breast Cancer – Metastatic

Monday, June 6
8:00 AM – 11:00 AM

Keun Seok Lee, M.D., M.S., Ph.D.

Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) and tislelizumab (TIS) as first line (1L) therapy for patients (pts) with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GEJC): Preliminary results from a Phase 1b/2 study.

Abstract Number: 4032

Poster session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Keun-Wook Lee, M.D., M.S., Ph.D.

AdvanTIG-206: Anti-TIGIT monoclonal antibody (mAb) ociperlimab (BGB-A1217; OCI) plus anti-programmed cell death protein 1 (PD-1) mAb tislelizumab (TIS) plus BAT1706 versus TIS plus BAT1706 as first-line (1L) treatment for advanced hepatocellular carcinoma (HCC)

Abstract Number: TPS4172

Poster session – Gastrointestinal cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Saturday, June 4
8:00 AM – 11:00 AM

Jia Fan, M.D.

BeiGene Online Only Abstracts at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Title

Abstract Number

Lead Author

Hematologic Malignancies Clinical Data

A phase 2 expanded access study of zanubrutinib (ZANU) in patients (pts) with Waldenström Macroglobulinemia (WM)

e19522

Jorge J. Castillo, M.D.

Solid Tumor Clinical Data

Clinical outcomes in patients (pts) with previously treated advanced hepatocellular carcinoma (HCC) experiencing hepatitis B virus (HBV) DNA increases during tislelizumab (TIS) treatment in RATIONALE-208.

e16181

Ann-Lii Cheng, M.D.

RATIONALE 302 PRO (encore): Tislelizumab versus chemotherapy as second-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life

e16095

Eric Van Cutsem, M.D., Ph.D.

Randomized, Phase 3 study of second-line tislelizumab versus chemotherapy in advanced or metastatic esophageal squamous cell carcinoma (ESCC), RATIONALE 302: Asia subgroup.

e16107

Kuaile Zhao, M.D.

Updated analysis from a Phase 2 study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable/metastatic microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors.

e14556

Jian Li, M.D., Ph.D

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 45 countries and regions, including the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

About Tislelizumab

Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for eight indications, including multiple approvals in non-small cell lung cancer (NSCLC). Tislelizumab is currently in regulatory review in first line recurrent/metastatic nasopharyngeal cancer in China and as a potential treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy in the U.S. and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the U.S., Europe, and Japan.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under U.S. Food and Drug Administration (FDA) review, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.