Samsung Biologics Reports Second Quarter 2022 Financial Results

On July 27, 2022 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported that strong financial results for the second quarter of fiscal year 2022 (Press release, Samsung BioLogics, JUL 27, 2022, View Source [SID1234617037]).

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John Rim, CEO of Samsung Biologics, stated, "Samsung Biologics delivered another strong quarterly performance ahead of our guidance with our revenue exceeding KRW 1 trillion for the first half of the year. Operations are seamless across all our plants, and the partial completion of Plant 4 is just around the corner, scheduled to commence operations in October this year. We completed a deal to fully acquire Samsung Bioepis, expanding and diversifying our revenue base and business portfolio. More recently, we have officially signed an agreement to purchase land for Bio campus II. All these factors signal that we have a strong momentum going, and that we are well on track in our expansion plans to serve the increasing market demands."

SECOND QUARTER 2022 RESULTS

Samsung Biologics demonstrated strong operational excellence and business agility in the second quarter with earnings exceeding initial projections.

Reporting under the consolidated approach for the first time since the acquisition in April, Samsung Biologics and Samsung Bioepis in the second fiscal quarter recorded a revenue of KRW 651.4 billion, operating profit of KRW 169.7 billion, and net profit of KRW 152 billion with EBITDA margin of 39.7%.

On a standalone basis, the second quarter 2022 revenue for Samsung Biologics was KRW 503.7 billion, an increase of 22.2% from KRW 412.2 billion reported for the second quarter in the previous year, due to efficiency in operations despite a scheduled slow-down of Plant 2, and attributable to the expansion of product sales.

Samsung Biologics also reported an operating profit of KRW 171.9 billion, 3.18% higher than the prior-year period, and a net profit of KRW 101.8 billion with an operating profit margin of 34.1% for the same quarter.

On a standalone basis, Samsung Bioepis earned KRW 232.8 billion in revenue, 24.2% higher than the prior-year period attributable to the increase in sales of its biosimilar products in global markets including the US and Europe. Samsung Bioepis’s operating profit increased significantly by 95.7% compared to the prior-year period, at KRW 58.5 billion.

FISCAL YEAR 2022 OUTLOOK

The construction of Samsung Biologics Plant 4 is on schedule with 6 X 10KL production capacity expected to commence operations in October. The company has secured a number of large scale manufacturing contracts with active presales activities for Plant 4, and at the close of Q2, in the first half of 2022 alone, the company had secured over USD 7.9 billion in sales backlog including deals with Janssen, Merck, GSK, Lilly, and Novartis to name a few.

Earlier this month, Samsung Biologics secured additional land sized at 357,366 ㎡ and approximately 30% larger than its current site, to support the build out of its second campus. At the newly acquired site, the company will host additional large-scale manufacturing facilities as well as an open innovation facility.

Samsung Biologics also published its second annual ESG Report this month, reflecting the company’s latest sustainability efforts to address a wide range of environmental, social, and governance (ESG) activities related to its business. The company aims to build an eco-friendly business environment and achieve net zero GHG emissions in its operations, and continue to enhance its social contribution activities that strive to support the health of its local communities.

Samsung Bioepis has a total of six biosimilar products approved and commercially available in different markets[1], and its revenue has steadily grown driven by increases in global product sales and milestone payments.

Of the six products, SB4, a biosimilar to Enbrel (etanercept), which was launched in Europe in 2016, has surpassed its originator’s sales in Europe by overtaking the majority of the market share, and the company recently launched SB11, a biosimilar to Lucentis (ranibizumab), in June 2022 in the US. With four additional biosimilar candidates in late stage development, Samsung Bioepis is solidifying its position as a leading company in the biosimilars industry.

For more details on performance and financials, please refer to the Earnings Release.

Ionis to hold second quarter 2022 financial results webcast

On July 27, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported that it will host a live webcast on Tuesday, August 9th at 11:30 a.m. Eastern Time to discuss its second quarter financial results and report on pipeline and business progress (Press release, Ionis Pharmaceuticals, JUL 27, 2022, View Source [SID1234617036]).

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The webcast may be accessed at View Source A replay will be available for a limited time at the same address.

PTC Announces Third fiscal Quarter 2022 Results

On July 27, 2022 PTC (NASDAQ: PTC) reported financial results for its third fiscal quarter ended June 30, 2022 (Press release, PTC Therapeutics, JUL 27, 2022, View Source [SID1234617035]).

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"In our third fiscal quarter, we again delivered strong results. We reported ARR growth of 9% and 15% on an organic constant currency basis. In addition, our recently acquired Codebeamer business had an outstanding quarter and added an additional point of ARR growth, taking constant currency ARR growth to 16%. In Q3, our cash from operations was $117 million, up 33% year over year, and our adjusted free cash flow was $132 million, up 23% year over year. The strength in Q3 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 leading SaaS capabilities position PTC to drive superior value for customers. Given the high resiliency of our business due to our subscription model coupled with our strong market position, as well as the strong execution of our teams, we are raising our key guidance measures for fiscal 2022 for the third time this year," concluded Heppelmann.

Third Quarter 2022 Highlights[1]

Key operating and financial highlights are set forth below. For additional details, please refer to the Q3’22 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, operating profit, and earnings per share are impacted by revenue recognition under ASC 606.

ARR as reported was $1,544 million at the end of Q3’22, up 9% compared to Q3’21, including $15 million related to the acquisition of Codebeamer. On a constant currency basis (including $16 million related to Codebeamer), ARR was $1,625 million, up 16%, compared to Q3’21. On an organic constant currency basis (excluding $16 million related to Codebeamer), ARR was $1,610 million, up 15% compared to Q3’21, and above guidance of $1,580 million to $1,595 million. Foreign exchange rate fluctuations had an $81 million negative impact on our Q3’22 reported ARR. ARR at the end of Q3’22 includes a $4 million reduction associated with discontinuing our business operations in Russia in Q2’22.
Cash flow from operations was $117 million, free cash flow was $112 million, and adjusted free cash flow was $132 million in Q3’22, up compared to Q3’21 by 33%, 33%, and 23%, respectively. All three metrics were above guidance. In Q3’21, cash flow from operations was $88 million, free cash flow was $85 million, and adjusted free cash flow was $107 million.
Revenue was $462 million in Q3’22, up 6% compared to Q3’21. On a constant currency basis, revenue was $480 million, up 12% compared to Q3’21.
Operating margin was 17% in both Q3’22 and Q3’21. Non-GAAP operating margin in Q3’22 was 34%, compared to 31% in Q3’21.
Earnings per share was $0.60 in Q3’22, compared to $0.43 in Q3’21. Non-GAAP earnings per share in Q3’22 was $0.97, compared to $0.83 in Q3’21.
Total cash and cash equivalents as of the end of Q3’22 was $322 million. Gross debt was $1.43 billion as of the end of Q3’22. The increase in gross debt during Q3’22 was primarily due to financing the Codebeamer acquisition with our revolving credit facility, partially offset by repaying $105 million on our revolving credit facility.
[1] The definitions of our operating and non-GAAP financial measures 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 Q4’22 Guidance

"PTC delivered solid third quarter results. Based on our Q3 performance and our forecast for the remainder of the year, including the impact of Codebeamer and DxP, we are raising our ARR and free cash flow and adjusted free cash flow guidance for fiscal 2022. Due to foreign exchange headwinds, we are reducing our revenue guidance," said Kristian Talvitie, EVP and CFO, PTC.

"Despite the foreign exchange headwinds and the impact of exiting our business in Russia in Q2’22, our resilient business model, consistent execution, and operational discipline position us to deliver on our updated targets for the year," concluded Talvitie.

Our FY’22 guidance now reflects the expected operating results of the Codebeamer business and the effect of the DxP transaction, as well as the impact of business combination accounting, incremental interest expense, and all acquisition and transaction-related charges.

Our FY’22 and Q4’22 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. Unfavorable changes in foreign exchange rates have been a headwind to our reported ARR. At end of Q3’22 foreign exchange rates, FY’22 ARR would be lower by approximately $85 million, compared to our constant currency guidance (previously $34 million, based on foreign exchange rates as of the end of Q2’22).
We expect FY’22 organic churn, excluding the impact of our exit from Russia, to improve by approximately 150 basis points (previously 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.
Our operating costs are expected to increase in FY’22 due to hiring, increased SaaS investments, merit increases that took effect in Q3’22, and the acquisition of the Codebeamer business in Q3’22 (updated). At the mid-point of ARR guidance, we expect FY’22 GAAP operating expenses to increase approximately 4% to 5% (previously 3% to 4%) and non-GAAP operating expenses to increase approximately 2% to 3% over FY’21.
FY’22 GAAP P&L results are expected to include the items outlined below, totaling $281 million to $291 million (previously $293 million to $308 million), as well as their related tax effects:
$170 million to $180 million (previously $160 million to $170 million) of stock-based compensation expense
$61 million (previously $58 million) of intangible asset amortization expense
$37 million (previously $35 million to $40 million) of restructuring charges
$11 million (previously approximately $5 million) of acquisition and transaction-related charges
$32 million (previously $35 million) of FY’22 net realized losses from the sale of investments
$30 million gain associated with the sale of a portion of our PLM service business (new)
Related to restructuring, for FY’22 we expect:
P&L charges of $37 million (previously $35 million to $40 million), which have been incurred in the first nine months of FY’22.
Cash outflows for restructuring payments of $40 million to $45 million, of which $38 million was paid in the first nine months of FY’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 $20 million (previously $25 million).
Our long-term goal, assuming our Debt/EBITDA ratio is below 3x, is to return approximately 50% of our free cash flow to shareholders via share repurchases, while also taking into consideration the interest rate environment and strategic opportunities (updated).
PTC’s Fiscal Third Quarter Results Conference Call

The Company will host a conference call to discuss results at 5:00 pm ET on Wednesday, July 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 and transaction-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): 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: We provide an ARR (Annual Run Rate) operating measure to help investors understand and assess the performance of our business as a SaaS and on-premise subscription company. 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.

Organic Constant Currency ARR: We provide an organic constant currency ARR measure to help investors understand and assess the performance of our business without the effect of ARR (other than insignificant amounts) from acquisitions in the comparative period and foreign exchange rate fluctuations.

Because our ARR measures represent the annualized value of customer contracts as of a point in time, they do not represent revenue for any particular period or remaining revenue that will be recognized in future periods.

Churn: We provide churn measures to enable investors to understand and assess our customer contract retention. Churn represents the difference between the ARR amount for all subscription software, cloud, SaaS, and support contracts ended within a reporting period and the annualized renewal transactions started within a reporting period, as of the end of the reporting period.

DURECT Corporation to Announce Second Quarter 2022 Financial Results and Provide Business Update on August 4

On July 27, 2022 DURECT Corporation (Nasdaq: DRRX) reported that it will report its first quarter 2022 financial results and host a conference call after the market close on Thursday, August 4, 2022 (Press release, DURECT, JUL 27, 2022, https://www.prnewswire.com/news-releases/durect-corporation-to-announce-second-quarter-2022-financial-results-and-provide-business-update-on-august-4-301594731.html [SID1234617034]).

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Vanda Pharmaceuticals to Announce Second Quarter 2022 Financial Results on August 3, 2022

On July 27, 2022 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported it will release results for the second quarter 2022 on Wednesday, August 3, 2022, after the market closes (Press release, Vanda Pharmaceuticals, JUL 27, 2022, View Source [SID1234617033]).

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Vanda will host a conference call at 4:30 PM ET on Wednesday, August 3, 2022, during which management will discuss the second quarter 2022 financial results and other corporate activities. To participate in the conference call, please dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use passcode 4304469.

The conference call will be broadcast simultaneously and archived on Vanda’s website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Wednesday, August 3, 2022, beginning at 8:30 PM ET and will be accessible until Wednesday, August 10, 2022, at 8:30 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 4304469.