On July 26, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that results for the second quarter of 2022 and increased the outlook for full-year 2022 (Press release, Qiagen, JUL 26, 2022, View Source [SID1234616948]).

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Net sales for Q2 2022 declined 9% (-4% at constant exchange rates, CER) to $516 million from Q2 2021. Sales at CER were $544 million, ahead of the outlook for at least $510 million CER. Sales were driven by 10% CER growth in the non-COVID-19 product portfolio to $423 million, but sales of COVID-19 products fell 39% CER to $92 million. Adjusted diluted earnings per share (EPS) were $0.51 ($0.53 CER) compared to $0.67 in Q2 2021, and ahead of the outlook for at least $0.46 CER.

Based on the strong performance in the first half of the year, QIAGEN has raised its full-year 2022 net sales outlook of at least $2.2 billion CER (prior outlook for at least $2.12 billion CER) and for adjusted diluted EPS of at least $2.30 CER (prior outlook for at least $2.14 CER). This update includes a reaffirmation of the goal for double-digit CER sales growth from the non-COVID product groups, which grew 12% CER in the first half of 2022, but for a decline in COVID-19 sales amid volatile pandemic trends. It also reflects a review of macro-economic trends, including inflation and energy supplies.

"QIAGEN continues to deliver in 2022, led by double-digit CER sales growth from our non-COVID product portfolio in the first half of the year as we steadily execute on our goals. These solid results give us renewed confidence to increase our full-year outlook for 2022 and position QIAGEN for solid growth beyond the COVID-19 pandemic," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "We are addressing the challenges of the macro-environment with actions that include securing supply chains and energy needs. We are accelerating our focused strategy to enhance our balanced portfolio serving Life Science and Molecular Diagnostics customers worldwide, investing into our Five Pillars of Growth and remaining ready to support COVID-19 testing needs as they develop."

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "Our results for the first half of 2022 in our non-COVID business are another confirmation of how QIAGEN is moving ahead from a position of strength to create and sustain our growth opportunities. In light of the strong operating cash flow, we are accelerating investments into our portfolio, especially R&D initiatives to expand the test menu on key automation systems. The acquisition of BLIRT S.A. is a reaffirmation of our disciplined capital deployment strategy as we seek various ways to create greater value for shareholders and our other stakeholders."

Please find a PDF of the full press release incl. tables here.

Investor presentation and conference call

A conference call is planned for Thursday, July 28, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation is planned to be available shortly before the conference call at View Source

On July 26, 2022 Prestige Biopharma Limited (hereafter referred to as "Prestige") and Intas Pharmaceuticals Limited (hereafter referred to as "Intas") reported that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige Biopharma´s bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan (Press release, Prestige BioPharma, JUL 26, 2022, View Source [SID1234616947]).

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Prestige´s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer including metastatic colorectal cancer, advanced non-small-cell lung cancer, advanced kidney cancer, certain types of epithelial cancers and cancers of the cervix. HD204 is currently in Phase III clinical development (SAMSON-II) and the US and EU filing is planned next year. Positive results were previously reported from the Phase I clinical trial (SAMSON-I) which evaluated the pharmacokinetics, safety and immunogenicity of HD204 to Avastin.

The partnership arrangement includes the exclusive rights for Intas and its affiliate Accord Healthcare that will commercialize the bevacizumab biosimilar in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan, leveraging their strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. As one of the key players in the global biosimilar market, Accord has a longstanding commitment to oncology with proven commercial capabilities and it currently supplies around one in three injectable oncology medicines in Europe.

This collaboration represents the successful execution of the company’s strategy to expand its market reach in Europe and Canada leveraging Accord’s strong global footprint and deep commercial expertise. The global sales of bevacizumab including its biosimilars were recorded at USD 6.4 billion1) last year and the market is expected to continue growing. Prestige’s HD204 with excellent cost competitiveness based on the company’s proprietary bevacizumab production technology will be providing affordable access to more patients in need.

Lisa S. Park, CEO of Prestige Biopharma, commented: "We are delighted to establish a partnership with Intas for the key markets, the US and Europe. Accord is the ideal partner to commercialize our bevacizumab biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets."

Binish Chudgar, Vice Chairman & Managing Director of Intas Pharmaceuticals, commented: "We are pleased to announce the collaboration with Prestige Biopharma. This collaboration is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar drugs for cancer patients globally."

On July 26, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin and natriuretic peptide receptor systems, reported preliminary fourth quarter 2022 Vyleesi product sales (Press release, Palatin Technologies, JUL 26, 2022, View Source [SID1234616946]). Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

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"We are pleased with Vyleesi’s momentum and our preliminary product sales results for the quarter ended June 30, 2022," stated Carl Spana, Ph.D., President and CEO of Palatin. "Our operating results, which includes significant increases across all sales and distribution value metrics, compared to both the prior quarter and the comparable quarter in 2021, continue to demonstrate Vyleesi’s potential within the female sexual healthcare market."

Preliminary fourth quarter ended June 30, 2022 Vyleesi results:

Net product revenue increased 225% over the prior quarter;
increased 600% over the comparable quarter in 2021.
Gross product sales increased 75% over the prior quarter;
increased 90% over the comparable quarter in 2021.
Total prescriptions dispensed increased 45% over the prior quarter;
increased 50% over the comparable quarter in 2021.
Preliminary Financial Information
The Vyleesi related financial and operating data for the fourth quarter of fiscal 2022 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, Palatin’s management and no independent accounting firm has audited, reviewed, compiled, or performed any procedures with respect to this preliminary financial data. There can be no assurance that Palatin’s actual results for this quarterly period will not differ from the preliminary financial and operating data and such changes could be material. In addition, Palatin’s estimate of Vyleesi product sales for the fourth quarter of 2022 should not be viewed as a substitute for full financial statements for the fourth quarter and full year of fiscal 2022 prepared in accordance with U.S. generally accepted accounting standards. Additional information that will be material to investors will be provided in the financial statements for the three and twelve months ended June 30, 2022, and, accordingly, investors should not place undue reliance on the limited preliminary information being provided herein.

About Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD.

Palatin is actively seeking Vyleesi collaborations for North America and for territories outside the currently licensed territories of China and Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea.

Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com.

On July 26, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported an update of its financial guidance for 2022, after preliminary completion of the latest evaluation of MorphoSys’ half year 2022 financial performance (Press release, MorphoSys, JUL 26, 2022, View Source [SID1234616945]).

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MorphoSys updates its financial guidance based on the preliminary unaudited consolidated results for the first six months 2022 and following the recent licensing agreements with Human Immunology Biosciences, Inc. (HIBio) for felzartamab and MOR210. Preliminary Monjuvi (tafasitamab-cxix) U.S. Net Product Sales are US$ 23.3 million (€ 21.7 million) for the second quarter of 2022 and US$ 41.9 million (€ 38.3 million) for the first half year 2022. For the full year of 2022, MorphoSys now expects Monjuvi U.S. Net Product Sales in the range of US$ 90 to US$ 110 million (previously: US$ 110 to US$ 135 million). Further, MorphoSys now expects R&D expenses in the range of € 275 to € 300 million (previously: € 300 to € 325 million) and SG&A expenses in the range of € 150 to € 165 million (previously: € 155 to € 170 million). The previous financial guidance for 2022 was provided by MorphoSys on January 7, 2022 and reiterated on March 16 2022 and May 4, 2022 and can be found at www.morphosys.com. Guidance for Gross Margin for Monjuvi U.S. Net Product Sales remains unchanged.

On July 26, 2022 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.69 per share of the company’s common stock for the fourth quarter of 2022 (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616944]). Payment will be made on Oct. 7, 2022, to shareholders of record at the close of business on Sept. 15, 2022.

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