Avid Bioservices Inc (CDMO)

[cjgaddy]

PPHM’s 10K Notes re: Avid FY18 & Beyond (FY18 Guidance announced 7-14-17: $50-55mm - http://tinyurl.com/yb4wulvu )

From 4-30-17 10K iss. 7-14-17 - http://tinyurl.com/ycxu4l5n

Pg.2: “With respect to our CDMO business, FY17 was a record year for revenues, topping $57mm, a 30% revenue growth over FY16 FY. While we are pleased at the continued yr-over-yr revenue growth, we have also recently seen unanticipated decreases in mfg. demand from our largest customer [Halozyme] and a recent regulatory filing delay from our 2nd largest customer which will have some impact on our ability to grow the revenues from our CDMO business in FY18 and could impact our ability to achieve overall profitability by q/e July 31, 2018. However, we believe this to be temporary delay in revenue growth during FY18 and have recently secured 4 new customers and are continuing to focus on securing addl. customer business in order to better diversify our customer base. Our goal is to maintain profitability for Avid over the short term while positioning the business for long-term growth and attracting the resources necessary to continue to advance our promising research and development efforts.”

Pg.3: “FY18 Key Objectives - Our CDMO Business
* Expand our mfg. capacity through the installation & validation of two 2,000L single-use bioreactors in our Myford Facility to support the anticipated needs of a current customer
* Continue to diversify our customer base by securing addl. customers to support our future revenue growth beyond FY18.”

Pg.31: “We have been developing and mfg. biologics since 1993 in our Franklin biomfg. facility (the “Franklin Facility”) located at our current headquarters in Tustin and formed Avid in 2002 to offer these services to 3rd-party customers using. In March 2016, we expanded our mfg. capacity through the launch of our Myford biomfg. facility (“Myford Facility”), which doubled our mfg. capacity. The 42,000sf facility, which is our 2nd biomfg. facility, can accommodate single-use bioreactors up to the 2,000-liter mfg. scale. The Myford Facility was designed to accommodate a fully disposable biomfg. process for products in late stage clinical dev. to commercial. To date, Myford Facility has been utilized to complete a number of process validation runs for our 3rd-party customers, which may lead to future commercial production, and has supported the process validation of our internal product, bavituximab. The Myford Facility is located adjacent to our Franklin Facility. As we look to expand our CDMO business, in Feb. 2017, we leased an addl. 42,000sf of vacant warehouse space within the same building as our existing Myford Facility. The proximity of this space will allow us to utilize existing mfg. infrastructure that we believe should enhance our mfg. efficiencies and reduce the overall cost and timeframe to construct a 3rd biomfg. facility. Although we previously anticipated that the new mfg. facility would be constructed and ready for mfg. activities by mid-calendar year 2018, due to unanticipated changes in and/or timing of customer demand (as discussed above), we have decided to defer construction of this 3rd facility until demand from existing or potential new customers is expected to exceed the current mfg. capacity at our Franklin Facility & Myford Facility. Additionally, commencement of construction is also subject to our ability to raise sufficient addl. capital to support this expansion effort. As a result, we presently do not expect to commence construction of this 3rd facility prior to April 30, 2018.”

Pg33: “Excluding any future potential new business, we expect Avid revs for FY18 to slightly decline vs. FY17. Part of this decline is due to lower anticipated commitments from Halozyme (our largest customer) based on their most recent committed forecast (covering the 3 qtrs ending March 2018), which amount is expected to be partially offset by $10mm revenue that was expected to be recognized in FY17, but has been shifted to FY18 due to a delay in shipping product that was complete and ready for shipment as of fye 4-30-17.”

= = = = = = = = = = = = = = = = = = = = = = =
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
7-14-17: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q4 (q/e 4-30-17): http://tinyurl.com/yb4wulvu (since 5-2006: Avid=$231.2mm, Total=$257.8mm, incl.Govt)
......Avid FY18 (fye 4-30-18) revs guidance: $50-55mm; committed backlog=$58mm. Recently Leased +42,000sf in same bldg. as MYFORD for future expansion."
7-14-17: Avid Scientists develop “Antibody Discovery & Characterization Platform” http://tinyurl.com/ycr3erft
...S.King: “through which we can generate antibodies against virtually any target. These capabilities are state-of-the-art and meant for rapid screening for high affinity antibodies as drug candidates.”
5-2017: Avid II (Myford) adds 2 MilliporeSigma Mobius 2,000L single-use bioreactors; total mfg. capacity now ">11,000L". http://tinyurl.com/ky7bmu4
5-10-17: Halozyme comments on Avid II(Myford) expansion in their 3-31-17/10Q pub. 5-9-17: http://tinyurl.com/mrl34uk
..."validation of the new facility is scheduled to end in Q2/2017… Once this new facility is approved, it will become the primary source for Roche of bulk rHuPH20.”