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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GSK delivers strong Q2 2022 sales of £6.9 billion +19% at AER, +13% at CER and Total EPS* from continuing operations** 17.5p -42% AER, -58% CER; Adjusted EPS of 34.7p +23% AER, +6% CER

On July 27, 2022 GSK reported that strong Q2 2022 sales of £6.9 billion +19% at AER, +13% at CER and Total EPS* from continuing operations** 17.5p -42% AER, -58% CER; Adjusted EPS of 34.7p +23% AER, +6% CER (Press release, GlaxoSmithKline, JUL 27, 2022, View Source [SID1234616985])

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Highlights
Strong commercial execution across Specialty Medicines, Vaccines and General Medicines drives double-digit sales growth
• Total sales: £6.9 billion +19% AER, +13% CER, excluding COVID-19 solutions +16% AER, +10% CER
– Specialty Medicines £2.7 billion +44% AER, +35% CER; HIV +14% AER, +7% CER; Oncology +29% AER, +23% CER; Immuno-inflammation and other specialty +32% AER +24% CER; COVID-19 solutions (Xevudy) sales £0.5 billion
– Vaccines £1.7 billion +9% AER, +3% CER; Shingrix £731 million >100% AER, >100% CER
– General Medicines £2.5 billion +5% AER, +2% CER

Continued cost discipline supports delivery of improved adjusted operating margin
• Total continuing operating margin 16%. Total EPS 20.8p -40% AER, -53% CER; Total continuing EPS 17.5p
-42% AER, -58% CER; primarily reflecting increased contingent consideration charges driven by exchange rates and adverse comparison due to a credit for the revaluation of deferred tax in Q2 2021
• Adjusted operating margin 29%. Adjusted operating profit growth +22% AER, +7% CER. The impact on growth from lower margin COVID-19 solutions was approximately -16% AER, -14% CER
• Adjusted EPS 34.7p +23% AER, +6% CER. The impact on growth from lower margin COVID-19 solutions was approximately -20% AER, -18% CER
• Q2 2022 continuing cash generated from operations £1.6 billion. Free cash flow £0.3 billion

Strengthening late-stage R&D pipeline with positive data read-outs and strategic business development
• US FDA approval for Priorix (MMR vaccine); Vocabria plus rilpivirine approval in Japan for HIV; Cervarix approval in China for cancer-causing human papillomavirus
• Positive phase III high-level results for respiratory syncytial virus vaccine candidate in older adults. Full results to be presented at an upcoming scientific meeting with regulatory submissions anticipated in H2 2022
• Proposed acquisition of Affinivax provides access to next-generation phase II 24-valent pneumococcal vaccine candidate and innovative MAPSTM technology
• Promising phase IIb interim data presented for bepirovirsen, a potential new treatment for chronic hepatitis B. Phase III monotherapy trial is anticipated to start in H1 2023
• Completed acquisition of Sierra Oncology on 1 July 2022. Data from momelotinib’s MOMENTUM phase III trial presented at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting; results showed a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anaemia. NDA submitted to the US FDA
• Phase III data readouts expected in H2 2022: pentavalent (MenABCWY) meningitis vaccine candidate, otilimab in rheumatoid arthritis, Jemperli in 1L endometrial cancer, and Blenrep in 3L multiple myeloma

Improving revenues and margin support confidence in full-year outlooks
• Expect 2022 sales growth of between 6% to 8% (previously 5% to 7%) and Adjusted operating profit growth of between 13% to 15% (previously 12% to 14%); both at CER. Adjusted EPS expected to grow by around 1% lower than operating profit. 2022 guidance excludes any contribution from COVID-19 solutions
• Dividend of 16.25p/share (13p before Share Consolidation) declared for Q2 2022. No change to expected dividend of 61.25p/share (49p before Share Consolidation) for FY 2022

Successful demerger and listing of Haleon on 18 July, creating a new global leader in consumer health
• Balance sheet strengthened for GSK, through dividend of more than £7 billion from Haleon

Q2 2022 infographic
Emma Walmsley, Chief Executive Officer, GSK said:
"This is GSK’s first set of results as a newly focused biopharma company, and we have delivered an excellent second quarter performance, with strong growth in Specialty Medicines, including HIV, and a record quarter for our shingles vaccine Shingrix. With this momentum in sales and operating profit growth, we have raised our full-year guidance and are confident in delivering the long-term growth outlooks we set out for shareholders last year. We continue to strengthen our pipeline, notably with very positive high-level results from our late-stage RSV vaccine candidate, together with targeted business development acquisitions of Sierra Oncology and Affinivax. These improvements in R&D and operating performance, together with a strengthened post-demerger balance sheet, create new capacity and flexibility for GSK to invest in growth and innovation for patients and shareholders."

*Earnings per share have been retrospectively adjusted to reflect the GSK Share Consolidation on 18 July 2022, see details on page 53 of the full announcement.
**Consumer Healthcare is now accounted for as a discontinued operation, see details on page 20 of the full announcement.

7th Annual CAR-TCR Summit

On July 27, 2022 EVERSANA reported at 7th Annual CAR-TCR Summit (Press release, EVERSANA, JUL 27, 2022, View Source [SID1234617003]).

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As the industry focuses more on specialty therapies, it is imperative that manufacturers move to a patient-centered care model that delivers value enabled by innovative technologies and measured by actionable data.

As the only go-to complete commercialization expert in the industry, EVERSANATM brings together strategy, patient recruitment for clinical trials, HCPs and patient engagement across the patient journey, and warehousing and logistics to support complex transportation needs.

Join EVERSANA’s Brian Urban, Senior Implementation Director and Seth Gordon, General Manager, EVERSANA INTOUCH Engage during their September 21st plenary presentation, "Incorporating Patient Insights & Engagement for Clinical & Commercial Success," at 8:40 am EST.

To schedule a meeting with our cell and gene therapy experts at the CAR-TCR Summit, click here.

UroGen Pharma to Report Second Quarter 2022 Financial Results on Thursday, August 11, 2022

On July 27, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will report second quarter 2022 financial results on Thursday, August 11, 2022, prior to the open of the market (Press release, UroGen Pharma, JUL 27, 2022, View Source [SID1234617019]). The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

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A live public webcast of the earnings conference call can be accessed on UroGen’s Investor Relations website. Following the live webcast, a replay will be available on the site for approximately 30 days.

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.