On August 10, 2022 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2022 (Press release, ChromaDex, AUG 10, 2022, View Source [SID1234618040]).

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Second Quarter 2022 and Recent Highlights

Total net sales were $16.7 million, with $14.5 million from Tru Niagen, down 5% and 6% from the prior year period, respectively.
Total net sales and Tru Niagen net sales remained relatively flat year over year excluding the initial shelf stocking sales to Wal-Mart in the second quarter of 2021. Sales were also impacted by the timing of shipments to Watson’s due to COVID-19 ($1.5 million versus $2.9 million in the prior year period).
Strong gross margin of 60% despite lower sales and inflationary pressures in global supply chains.
General and administrative expense decreased $2.0 million from the prior year quarter driven by lower legal expense.
Announced agreement to launch commercial joint venture in Mainland China, marking an expansion milestone for the brand in a strategic market. Signed agreement with Sinopharm Xingsha to accelerate cross-border sales of Tru Niagen.
Partnered with Juvenis for cross-border sales of Tru Niagen into South Korea, furthering Asia expansion strategy.
In May 2022, the ChromaDex External Research Program (CERP) was honored in the "Nutrition Research Project" category for pioneering research behind Niagen.
"Our team is doing great work in a challenging environment," said CEO Rob Fried. "The e-commerce business continues to grow, and we are excited about our new partnerships in China and South Korea. We are placing greater emphasis on operating efficiency and profitable growth in the second half of the year."

Results of operations for the three months ended June 30, 2022 compared to the prior year quarter

For the three months ended June 30, 2022 ("Q2 2022"), ChromaDex reported net sales of $16.7 million, a decrease $1.0 million or (5)% compared to the second quarter of 2021 ("Q2 2021"). The decline in Q2 2022 revenues compared to Q2 2021 was related to the initial shelf stocking in Wal-Mart to support our launch in the prior quarter driving increased sales in Q2 2021, paired with lower sales to A.S. Watson, a related party, during Q2 2022, which was impacted by timing of shipments due to COVID-19. These declines were largely offset by growth in e-commerce sales of Tru Niagen.

Gross margin percentage declined to 60.0% in Q2 2022 compared to 61.1% in Q2 2021 primarily due to business mix and increases in supply chain headcount to scale the business.

Operating expense was flat at $16.4 million in Q2 2022, compared to $16.4 million in Q2 2021. For operating expense, there was a $2.0 million decrease in general and administrative expense which was largely offset by $1.8 million of higher selling and marketing expense. The increase in selling and marketing expense was related to brand building activities, including the new Tru Niagen television campaign. We expect to scale back our larger brand campaigns in the second half of 2022, as we shift our focus to more efficient distribution channels, primarily e-commerce, coupled with overall expense management.

The net loss for Q2 2022 was $6.4 million or $(0.09) per share compared to a net loss of $5.6 million or $(0.08) per share for Q2 2021. Adjusted EBITDA including legal expense, a non-GAAP measure, delivered a loss of $4.6 million for Q2 2022, a $1.1 million decline from Q2 2021. Adjusted EBITDA excluding legal expense, a non-GAAP measure, was a loss of $2.9 million for Q2 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP measures to net loss, the most directly comparable GAAP measure.

For Q2 2022, net cash outflow from operating activities was $3.8 million, compared to $7.9 million in Q2 2021 largely due to changes in working capital including improvements in the collections of trade receivables.

2022 Full Year Outlook

Looking forward, for the full year, the Company expects high single digit revenue growth, driven by its global e-commerce business, offset by slower growth with new, and existing, partners. For the full year, the Company expects approximately 60% gross margin, selling and marketing expense will be down as a percentage of net sales, approximately $1 million increase in R&D, and approximately $6 to 7 million decrease in general and administrative expense, as reported, driven by lower legal expense. The Company expects to approach cash flow break-even in the third quarter and be cash flow break-even or better in the fourth quarter of 2022. The Company considers Adjusted EBITDA including legal expense, a non-GAAP metric, to be a proxy for cash flow before working capital investments, and is targeting cash flow break-even on that basis.

Investor Conference Call

A live webcast will be held Wednesday, August 10, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 10, 2022 to 11:59 p.m. Eastern time on August 17, 2022. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

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.