On August 10, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2022, and provided a business update (Press release, Ascendis Pharma, AUG 10, 2022, View Source [SID1234618039]).

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"Our anticipated launch of TransCon PTH in the U.S. next year, combined with our progress towards making SKYTROFA the leading product in a growing growth hormone market, moves us closer to fulfilling our Vision 3×3 and becoming a sustainable, profitable, leading biopharma company," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.

Company Highlights & Progress

TransCon hGH:
SKYTROFA revenue continued to double quarter-to-quarter, reaching €4.4 million in the second quarter.

In June 2022, submitted a trial protocol to the FDA to evaluate TransCon hGH in Turner Syndrome.
The foresiGHt Trial in adult GHD on track to complete enrollment by the end of 2022.
Enrollment in the riGHt Trial, a Phase 3 trial in Japan for pediatric GHD, is expected to complete by the end of 2022.
Commercial launch of TransCon hGH planned for Europe in mid-2023.
TransCon PTH:
Following pre-NDA meeting with the FDA, on track to submit regulatory filing in the U.S. during the third quarter of 2022, with expected U.S. launch in mid-2023.
EU MAA submission planned during the fourth quarter of 2022.
After more than two years of treatment in the open-label extension portion of the Phase 2 PaTH Forward Trial, 57 out of 59 original subjects continue in the open label extension portion of the trial as of June 30, 2022.
In the Phase 3 PaTHway Trial, 79 out of 79 patients completed one-year follow-up; 78 out of 79 patients continue in the open-label extension portion of the trial as of June 30, 2022.
TransCon CNP:
Top-line data from the ACcomplisH Trial, a Phase 2 randomized, double-blind, placebo-controlled clinical trial in North America, Europe, and Oceania in children ages 2-10 years with achondroplasia expected in the fourth quarter of 2022.
Planned fourth-quarter regulatory submissions for a new global randomized, double-blind, placebo-controlled Phase 2b trial of TransCon CNP in children down to 2 years of age with achondroplasia.
TransCon TLR7/8 Agonist:
Enrollment continues in transcendIT-101, a Phase 1/2 trial of TransCon TLR7/8 Agonist with or without a checkpoint inhibitor in patients with advanced or metastatic solid tumors who have failed prior lines of therapy.
transcendIT-101 monotherapy and combo-therapy dose escalation top-line data are expected during the third quarter of 2022.
TransCon IL-2 β/γ:
The Phase 1/2 IL-βelieγe Trial evaluating TransCon IL-2 β/γ monotherapy in patients with locally advanced or metastatic solid tumors continues to enroll patients. The Phase 1/2 IL-βelieγe Trial top-line data are expected in the fourth quarter of 2022.
During the second quarter of 2022, dosed first patient in combination checkpoint inhibitor and TransCon IL-2 β/γ dose-escalation arm of the IL-βelieγe Trial.
TransCon TLR7/8 Agonist and TransCon IL-2 β/γ Combination Therapy:
Plan to submit an IND or similar for Phase 2 cohort expansion for TransCon TLR7/8 Agonist and TransCon IL-2 β/γ during the fourth quarter of 2022.
Board of Directors to nominate Bill Fairey, and Siham Imani, both leaders in pharmaceutical commercialization, as new independent board members. The Board of Directors will call into an Extraordinary General Meeting to take place first half of September 2022.
Ended the second quarter of 2022 with cash, cash equivalents, and marketable securities totaling €995 million.
Second Quarter 2022 Financial Results

Total revenue for the second quarter was €6.2 million compared to €1.0 million in the same quarter of 2021. Revenue included U.S. revenue from SKYTROFA, as well as license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals. The increase in revenue compared to the same period the prior year was primarily attributable to the €4.4 million commercial revenue from SKYTROFA (lonapegsomatropin-tcgd) in the second quarter following U.S. commercial launch in October 2021.

Research and development (R&D) costs for the second quarter were €90.4 million compared to €83.3 million during the same period in 2021, reflecting primarily higher employee costs resulting from an increase in the number of R&D related personnel.

Selling, general, and administrative (SG&A) expenses for the second quarter were €56.6 million compared to €35.3 million during the same period in 2021. Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel following the launch of SKYTROFA.

Our share of net loss of associate was €1.2 million in the second quarter, compared to a net loss of €4.8 million during the same period in 2021.

Net finance income was €61.7 million in the second quarter compared to a net finance expense of €12.0 million in the same period in 2021.

For the second quarter of 2022, Ascendis Pharma reported a net loss of €81.3 million, or €1.46 per share (basic and diluted) compared to a net loss of €134.4 million, or €2.50 per share (basic and diluted) for the same period in 2021.

As of June 30, 2022, Ascendis Pharma had cash, cash equivalents, and marketable securities totaling €994.9 million compared to €789.6 million as of December 31, 2021. As of June 30, 2022, Ascendis Pharma had 56,965,058 ordinary shares outstanding.

Conference Call and Webcast Information

Ascendis Pharma will host a conference call and webcast today at 4:30 pm Eastern Time (ET) to discuss its second quarter 2022 financial results.

Those who would like to listen to the live webcast can access it through the following link. To access the live teleconference, register online here. Participants are encouraged to register at least 15 minutes prior to the call.

A replay of the webcast will be available on the Investors & News section of the Ascendis Pharma website at View Source shortly after conclusion of the event for 30 days.

On August 10, 2022 Athenex, Inc. ("Athenex") (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it intends to offer and sell, subject to market conditions, shares of its common stock, or pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants to purchase shares of its common stock, in an underwritten public offering (Press release, Athenex, AUG 10, 2022, View Source [SID1234618038]). All of the shares of common stock, warrants and pre-funded warrants are being offered by Athenex.

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SVB Securities is acting as sole book-running manager for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there by any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On August 10, 2022 2seventy bio, Inc. Presented the Corporate Presentation (Presentation, 2seventy bio, AUG 10, 2022, View Source [SID1234618037]).

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On August 10, 2022 Genmab reported Interim Report for the First Six Months Ended June 30, 2022 (Press release, Genmab, AUG 10, 2022, View Source [SID1234618036])

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Highlights

Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab from the Phase 1/2 trial in patients with relapsed/refractory large B-cell lymphoma (LBCL)
Genmab announced its intent to submit a biologics license application (BLA) to the U.S. Food and Drug Administration (U.S. FDA) for epcoritamab for the treatment of patients with relapsed/refractory LBCL, in the second half of 2022
DARZALEX net sales as reported by Johnson & Johnson increased 37% compared to the first six months of 2021 to USD 3,842 million, resulting in royalty revenue to Genmab of DKK 4,024 million
Genmab announced the resolution of its arbitration with Janssen Biotech, Inc. (Janssen) under its daratumumab license agreement and subsequently commenced a new arbitration under the daratumumab license agreement with Janssen
Genmab improves its 2022 financial guidance

Genmab’s innovation was on display during the second quarter of 2022 with data presentations at multiple prestigious conferences and the publication by Genmab, and our partner, AbbVie, of topline results for epcoritamab from the Phase 1/2 trial in patients with relapsed/refractory LBCL. Based on this data, we intend to submit a BLA to the U.S. FDA for epcoritamab in the second half of this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2022

Net sales of DARZALEX by Janssen were USD 3,842 million in the first six months of 2022 compared to USD 2,798 million in the first six months of 2021, an increase of USD 1,044 million, or 37%.
Royalty revenue was DKK 4,727 million in the first six months of 2022 compared to DKK 2,595 million in the first six months of 2021, an increase of DKK 2,132 million, or 82%. The increase in royalties was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta and higher average exchange rate between the USD and DKK.
Revenue was DKK 5,281 million for the first six months of 2022 compared to DKK 3,553 million for the first six months of 2021. The increase of DKK 1,728 million, or 49%, was primarily driven by higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations with Janssen, Roche and Novartis Pharma AG (Novartis), respectively, partly offset by milestones achieved under our collaborations with Janssen and AbbVie in the first six months of 2021.
Operating expenses were DKK 3,520 million in the first six months of 2022 compared to DKK 2,234 million in the first six months of 2021. The increase of DKK 1,286 million, or 58%, was driven by the continued advancement of epcoritamab and multiple pipeline projects, an increase in new employees to support Tivdak post launch and expansion of our product pipeline, and the continued development of Genmab’s commercialization and broader organizational capabilities and infrastructure.
Operating profit was DKK 1,761 million in the first six months of 2022 compared to DKK 1,319 million in the first six months of 2021.

Outlook
As announced in Company Announcement No. 40, Genmab is raising its 2022 financial guidance published on May 11, 2022, driven primarily by increased royalty revenue due to higher net sales of DARZALEX and the foreign exchange impact of the strong US Dollar.

Genmab will hold a conference call in English to discuss the results for the first half of 2022 today, Wednesday, August 10, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333000804 (international participants) and provide conference code 29756170. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

On August 10, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales of $50.2 million for the month of July 2022 (Press release, Pacira Pharmaceuticals, AUG 10, 2022, View Source [SID1234618014]). The company’s net product sales include EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

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"We are pleased to report continued EXPAREL growth despite lingering market disruptions. This solid performance underscores expanding adoption as the market continues to recognize the significant advantages of EXPAREL-based opioid-sparing approaches for postsurgical pain," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "We are rolling out key partnerships that provide a clear pathway for expanding our customer base by supporting training and education around EXPAREL best-practice across multiple service lines. Our ZILRETTA franchise continues to perform well and remains in the early stage of its growth trajectory. In addition, the market feedback around our Generation-2 iovera° device continues to be positive and we remain confident the product will return to more robust growth as the year progresses. On the clinical front, we are working diligently to advance a pipeline of new growth opportunities with top line results for our two Phase 3 studies of EXPAREL as a lower extremity nerve block on track for the third and fourth quarters."

July 2022 Preliminary Net Product Sales Highlights

EXPAREL net product sales were $40.9 million in each of July 2022 and 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of July 2022 were 105 percent of July 2021. The number of EXPAREL selling days were 20 in July 2022 and 21 in July 2021.
ZILRETTA net product sales were $8.2 million for July 2022. ZILRETTA sales in July 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
iovera° net product sales were $1.1 million for July 2022, compared with $1.0 million for July 2021.
Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2022.