Quarterly Management Statement for the Period Ending September 30, 2015
Spotlight on oncology based on further strengthened financial position
R&D and Operating Highlights:
- Clinical development of MP0250, the lead multi-DARPin oncology asset, is progressing
- Interim clinical data from a Phase I study of MP0250 accepted for poster presentation at AACR-NCI-EORTC International Conference on Molecular Targets on November 7, 2015 in Boston
- Advancing company’s proprietary oncology pipeline, including MP0274 and several immuno-oncology compounds, remains core priority
- Allergan has initiated two pivotal phase III registration trials of abicipar for the treatment of wet age-related macular degeneration
- Allergan has committed to maintaining a broad research alliance on several DARPin programs, including multi-DARPin VEGF/PDGF
- Allergan paid USD 15 million in milestone payments following the start of phase III trials of abicipar and made USD 35 million in additional accelerated milestone payments tied to the research collaboration
- Molecular Partners was awarded the 2015 European Biotechnica Award which recognized the company’s DARPin drug discovery platform and advancements made toward bringing novel therapeutic options to patients
- Strengthened financial position with CHF 221 million in cash and cash equivalents at September 30, 2015, up 26% since June 2015 and 130% year-over-year
- Operating profit of CHF 2.2 million and net profit of CHF 5.5 million in the third quarter of 2015
- Positive cash flow from operations of CHF 43.3 million in the third quarter of 2015
- Growing talent base with 86 full-time employees as of September 30, 2015
Zurich, October 29, 2015. Molecular Partners AG (ticker symbol: MOLN) today announced its Quarterly Management Statement for the period ending September 30, 2015 and key financial highlights for the third quarter 2015.
“We are very pleased with the significant progress made in our proprietary oncology pipeline, the initiation of our phase III abicipar program in collaboration with Allergan, our strengthened capabilities in oncology and our sound financial performance,” said Dr. Christian Zahnd, Chief Executive Officer of Molecular Partners. “We look forward to the upcoming AACR-NCI-EORTC International Conference on Molecular Targets on November 7 where we will present the first clinical data of MP0250, our proprietary lead oncology asset. As we continue to make investments in our oncology pipeline, this represents a key milestone for Molecular Partners.”
Important progress in proprietary oncology pipeline
Molecular Partner’s key focus remains on advancing the company’s proprietary oncology pipeline. The underlying multi-DARPin approach addresses multiple pathways with the hope of achieving higher efficacy while maintaining a favorable safety profile, possibly allowing for further combination with other therapies.
MP0250, the most advanced systemic DARPin, entered phase I studies in July 2014 for the treatment of solid tumors. On November 7, 2015, interim clinical data from a phase I dose escalation study will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets in Boston by Prof. Dr. Jordi Rodon, Vall D’Hebron Institute of Oncology, Barcelona, a principal investigator. MP0250 is a multi-DARPin inhibiting both vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) from binding to their receptors, thereby blocking tumor growth and tumor proliferation. Preliminary data from the phase I study of MP0250 shows it to be well tolerated, to have a mean half-life of around 11 days and to have sustained exposure on repeated dosing. In addition, there was disease stabilization exceeding 8 months in two patients suggestive of anti-tumor activity. Further dose escalation is ongoing.
Significant progress has also been made with MP0274, a molecule targeting HER2 that broadly blocks HER-mediated downstream signaling, leading to induction of apoptosis in preclinical studies conducted to date. Further, Molecular Partners has confirmed its proprietary research focus in immuno-oncology.
Key milestones reached in alliance with Allergan
Allergan announced in July 2015 the initiation of two pivotal phase III studies in wet AMD with abicipar, triggering a milestone payment of USD 15 million. The commencement of the first late stage clinical trial of a product from the DARPin platform represents a pivotal moment for Molecular Partners. Allergan has demonstrated its commitment to the robust research alliance with Molecular Partners with a USD 35 million accelerated milestone payment in the third quarter of 2015. Molecular Partners continues to leverage the potential of the DARPin technology in ophthalmology in collaboration with Allergan.
European Biotechnica Award 2015
In early October 2015, Molecular Partners was honored with the European Biotechnica Award to recognize the company’s truly disruptive and pioneering DARPin drug discovery platform as well as the advancements the company has made toward bringing novel therapeutic options to patients.
Financial Highlights: Milestone payments increase cash position
Molecular Partners’ financial development for the first nine months of 2015 remains in line with management’s expectations. In the third quarter of 2015, Molecular Partners recognized total revenues of CHF 9.9 million (3Q 2014: CHF 6.7 million) and incurred total expenses of CHF 7.7 million (3Q 2014: CHF 5.9 million). This led to an operating profit of CHF 2.2 million for the quarter (3Q 2014: CHF 0.8 million). The company recognized a net financing income of CHF 3.3 million, mainly driven by positive FX effects on USD and EUR cash positions (3Q 2014: CHF 0.3 million). This resulted in a 3Q 2015 net profit of CHF 5.5 million (3Q 2014: CHF 1.1 million).
The milestone payments from Allergan were collected in the third quarter and triggered a CHF 43.3 million net cash inflow from operating activities (3Q 2014: CHF -4.7 million). The milestone payments increased the cash and cash equivalents position by CHF 45.4 million to CHF 221.0 million as of September 30, 2015 (June 30, 2015: CHF 175.6 million). The total shareholders’ equity position increased to CHF 149.4 million as of September 30, 2015 (June 30, 2015: CHF 143.0 million).
As of September 30, 2015, the company employed 85.6 FTEs, with 90% of employees in R&D. (June 30, 2015: 83.0 total FTEs; September 30, 2014: 75.1).
Key figures as of September 30, 2015
(CHF million, except per share and FTE data)
|Operating profit (loss)||2.2||0.8||1.4||-1.7||2.3||-4.0|
|Net finance income (expenses)||3.3||0.3||3.0||0.2||0.3||-0.1|
|Net profit (loss)||5.5||1.1||4.4||-1.5||2.6||-4.1|
|Basic net profit (loss) per share (in CHF)||0.28||0.76||-0.48||-0.08||1.79||-1.87|
|Diluted net profit (loss) per share (in CHF)||0.25||0.66||-0.41||-0.08||1.57||-1.65|
|Net cash from (used in) operating activities||43.3||-4.7||48.0||34.1||-1.5||35.6|
|Net increase (decrease) in cash & cash equiv.||45.4||-3.0||48.4||32.6||-0.1||32.7|
|Cash & cash equivalents at Sep 30||221.0||96.0||125.0|
|Total shareholders’ equity at Sep 30||149.4||51.7||97.7|
|Number of total FTE at Sep 30||85.6||75.1||10.5|
|– thereof in R&D||77.4||68.3||9.1|
|– thereof in G&A||8.2||6.8||1.4|
“The collection of the two milestone payments from Allergan during the third quarter enhanced our already comfortable financial position,” said Andreas Emmenegger, Chief Financial Officer of Molecular Partners. We will close the full year 2015 with a positive net cash flow, which provides us with the strategic flexibility to invest the additional cash into our fully-owned DARPin program to maximize the commercial potential of these proprietary product candidates.
In oncology, Molecular Partners will present interim data of the ongoing phase I study for its lead proprietary oncology asset MP0250 at the AACR-NCI-EORTC International Conference on Molecular Targets on November 07, 2015 in Boston. The company’s management team also remains committed to progressing MP0274 from preclinical to clinical development in 2016.
In ophthalmology, Molecular Partners remains focused on supporting its partner Allergan as it progresses abicipar through the two phase III trials and to leverage the DARPin platform by advancing the earlier stage ophthalmology pipeline, including the multi-DARPin VEGF/PDGF.
Financially, Molecular Partners expects for the full year 2015, at constant exchange rates, total expenses of around CHF 35 million, of which around CHF 30 million are cash effective. Additionally, we expect approximately CHF 3 million of capital expenditures. Further, the company will generate a positive operational and net cash flow for full year 2015.
Financial Calendar 2016
|Publication of Full-year Results 2015||04 February 2016|
|Annual General Meeting of Molecular Partners AG||20 April 2016|
About Molecular Partners AG
Molecular Partners is a public, clinical stage, biopharmaceutical company listed on the SIX Swiss Exchange (ticker symbol: MOLN) that is developing a new powerful class of therapies known as DARPins. DARPins are potent, specific and versatile small protein therapies which have the potential to offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology has the potential to enable a multi-specific approach to treatment which enables DARPins to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPins have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders.
Molecular Partners has four compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. Its most advanced product candidate is abicipar. The company has ongoing research and development partnerships with leading pharmaceutical companies including Allergan and Janssen and is backed by established biotech investors. For more information regarding Molecular Partners, go to: www.molecularpartners.com.
For further details please contact:
Dr. Christian Zahnd, CEO
Dr. Patrick Amstutz, COO
Tel: +41 (0) 44 755 77 00
Tel: +41 (0) 43 344 42 42
Tel: +44 (0) 208 877 8400
This announcement is not an offer to sell, or a solicitation of an offer to purchase, any securities of Molecular Partners AG (the “Company”), nor shall it or any part of it form the basis of, or be relied on in connection with any contract or investment decision. This announcement is not for publication or distribution (directly or indirectly) in or to the United States, Canada, Australia, Japan or any other jurisdiction in which such distribution would be unlawful.
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The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. Neither the Company nor any other person undertakes any obligation to review, update, confirm, or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.